A Phase 2 interventional study of Bevacizumab and Cisplatin in Osteosarcoma and Malignant Fibrous Histiocytoma (MFH) of Bone, sponsored by St. Jude Children's Research Hospital. Completed at 5 sites in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2023-08-07.
Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment
This study adopts a novel strategy for first-line treatment of osteosarcoma by combining chemotherapy with anti-angiogenic therapy using bevacizumab (Avastin®), a humanized monoclonal antibody against vascular endothelial growth factor (VEGF). Chemotherapy for localized disease comprises a 3-drug regimen (cisplatin, doxorubicin, and high-dose methotrexate). Chemotherapy for metastatic or unresectable disease comprises a cisplatin-based regimen that includes high-dose methotrexate, doxorubicin, ifosfamide, and etoposide.
This is a comprehensive study that uses a novel agent that targets angiogenesis (bevacizumab) in combination with conventional chemotherapy for the treatment of osteosarcoma. Bevacizumab, a monoclonal antibody against the vascular endothelial growth factor (VEGF), has been shown to stop the growth of new blood vessels of tumors, both in the laboratory and in patients with other types of cancers. Bevacizumab has improved the effect of chemotherapy in adult patients with different types of cancer by increasing tumor response and increasing the chances of survival. This study has two main goals:
The chemotherapy drugs used in this study are commonly used to treat osteosarcoma. Patients with non-metastatic and resectable tumors receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate. Patients with metastatic tumors or tumors that cannot be removed by surgery receive bevacizumab and chemotherapy comprised of cisplatin, doxorubicin and high-dose methotrexate, ifosfamide and etoposide. If the tumor can be removed by surgery, surgery will be performed after 10 weeks of chemotherapy and will be followed by additional chemotherapy. After completion of active therapy, patient's response to therapy will be followed for approximately 5 years.
437 studies on the registry are indexed under Osteosarcoma; 116 are open to participants now.
This study's enrollment of 43 is close to the median of 42 across 325 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with localized resectable disease receive Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin, and doxorubicin, or methotrexate. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, or methotrexate.
Biological: Bevacizumab · Drug: Cisplatin · Drug: Doxorubicin · Drug: Methotrexate · Procedure: Surgery
Participants with metastatic disease (Stratum B) receive Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin and doxorubicin, methotrexate or ifosfamide, and etoposide. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, methotrexate, or ifosfamide, and etoposide. Radiotherapy will be given post-operatively.
Biological: Bevacizumab · Drug: Cisplatin · Drug: Doxorubicin · Drug: Methotrexate · Drug: Ifosfamide · Drug: etoposide · Procedure: Surgery · Radiation: Radiotherapy
Participants with unresectable disease (Stratum C) receive treatment identical to Stratum B: Cycle 1 of bevacizumab 3 days before chemotherapy with cisplatin and doxorubicin. Subsequent cycles consist of bevacizumab on the first day of chemotherapy, then cisplatin and doxorubicin, methotrexate or ifosfamide, and etoposide. If applicable, definitive surgery and assessment of histologic response will occur at week 10 followed by bevacizumab on the first day of chemotherapy with cisplatin and doxorubicin, methotrexate, or ifosfamide, and etoposide. Radiotherapy will be given post-operatively.
Biological: Bevacizumab · Drug: Cisplatin · Drug: Doxorubicin · Drug: Methotrexate · Drug: Ifosfamide · Drug: etoposide · Procedure: Surgery · Radiation: Radiotherapy
Monoclonal Antibody against vascular endothelial growth factor (VEGF). Given intravenously (IV).
Also known as: rhuMAb VEGF, Avastin®
Given IV.
Also known as: Platinol-AQ®
Given IV.
Also known as: Adriamycin®
Given IV.
Also known as: MTX
Given IV.
Also known as: Ifex®
Given IV.
Also known as: VP-16, Vepesid®
Participants undergo definitive surgery and assessment of histologic response at week 10.
Radiation therapy delivered for positive margins or intralesional resections.
Number of Participants With Unacceptable Toxicity
Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma. The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications. A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.
Time frame: After all patients have completed therapy, up to 1 year after last patient is enrolled
3-Year Event Free Survival
To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate.
Time frame: After all patients have completed therapy, up to 4 years after last patient is enrolled
Histologic Response by Stratum
The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133. Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor). The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done.
Time frame: After 6 cycles of chemotherapy, up to 1 year after the start of therapy
2-Year Event Free Survival (EFS) of Patients With Osteosarcoma
Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.
Time frame: After all patients have completed therapy, up to 2 years after last patient is enrolled
2-Year Overall Survival (OS) of Patients With Osteosarcoma
Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.
Time frame: After all patients have completed therapy, up to 2 years after last patient is enrolled
2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol.
The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here.
Time frame: After all patients have completed therapy, up to 2 years after last patient is enrolled
2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol.
The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here.
Time frame: After all patients have completed therapy, up to 2 years after last patient is enrolled
Mean Ktrans
The volume transfer constant (Ktrans) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.
Time frame: Baseline through Week 10
Mean Vp
The fractional blood plasma volume (Vp) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.
Time frame: Baseline through Week 10
Mean Ve
The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.
Time frame: Baseline through Week 10
Histologic Response by Number of Participants
The association of interested variables with response was checked with the Wilcoxon rank-sum test. The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.
Time frame: at week 10 after start of therapy
Ktrans by Good and Poor Response
The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.
Time frame: at week 10 after start of therapy
P95 of Ktrans by Good and Poor Response
The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. P95 denotes the level of each kinetic parameter exceeding 95% of its values in each tumor.
Time frame: at week 10 after start of therapy
Difference Between Good and Poor Response by SUVmax
The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.
Time frame: at week 10 after start of therapy
Number of Participants With Neuropathic Pain (NP) Following Surgery
Of the 43 participants enrolled on this trial, 37 met criteria for evaluation of neuropathic pain (NP) following definitive surgery. The 37 participants underwent 38 surgeries: one participant had a limb-sparing surgery followed by an amputation surgery. Six of 43 participants were excluded from evaluation for NP: 1 due to deep vein thrombosis, 2 removed from study prior to surgery, 1 removed immediately after surgery to receive radiation therapy, 1 had non-extremity osteosarcoma, and 1 patient had a fibula resection. Patients were followed for neuropathic pain daily for the first week postoperatively and weekly for up to 6 months postoperatively.
Time frame: Up to 6 months postoperatively
Median Duration of Neuropathic Pain
Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.
Time frame: From surgery until resolution of NP symptoms, up to 6 months
Mean Duration of Neuropathic Pain
Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.
Time frame: From surgery until resolution of NP symptoms, up to 6 months
Median Duration of Neuropathic Pain Medication
Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.
Time frame: From surgery until resolution of NP symptoms, up to 6 months
Mean Duration of Neuropathic Pain Medication
Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.
Time frame: From surgery until resolution of NP symptoms, up to 6 months
Forty-three participants were enrolled between June 2008 and May 2012: 34 at St. Jude Children's Research Hospital, 6 at Rady Children's Hospital San Diego, 2 at Johns Hopkins University Hospital, and 1 at M.D. Anderson in Houston
| Milestone | A: Localized Resectable Disease | B: Localized Unresectable Disease | C: Metastatic Tumors |
|---|---|---|---|
| Started | 31 | 0 | 12 |
| Completed | 17 | 0 | 3 |
| Not completed | 14 | 0 | 9 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Physician decision | 3 | 0 | 0 |
| Withdrew: Relapse or tumor progression | 9 | 0 | 7 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Ineligible | 0 | 0 | 1 |
Objective: To study the feasibility of combining: 1) bevacizumab with cisplatin, doxorubicin, and high-dose methotrexate (MAP) in patients with localized resectable osteosarcoma; and 2) bevacizumab with MAP and ifosfamide, and etoposide in patients with unresectable or metastatic osteosarcoma. The target unacceptable toxicity is defined as grade 4 hypertension, proteinuria, or bleeding excluding petechiae/purpura, grade 3/4 thrombosis/embolism excluding catheter-related thrombosis. The unacceptable toxicity for major wound complication is defined as grade 2, 3, or 4 major wound complications. A six-stage group sequential stopping rule was developed for monitoring unacceptable toxicity.
| participants | A: Localized Resectable Disease | C: Metastatic Tumors |
|---|---|---|
| Grade 4 Hypertension | 0 | 0 |
| Grade 4 Proteinuria | 0 | 0 |
| Grade 4 Bleeding | 0 | 0 |
| Grade 3/4 Thrombosis/Embolism | 1 | 0 |
| Grade 2, 3 or 4 Major Wound Complication | 7 | 2 |
To study the effect of adding bevacizumab to chemotherapy comprised of cisplatin, doxorubicin, and high-dose methotrexate (HDMTX) on the event-free survival (EFS) in patients with localized resectable osteosarcoma. The Kaplan-Meier (K-M) method was used to estimate survival rate.
| Probability | A: Localized Resectable Disease |
|---|---|
| 3-Year Event Free Survival | 0.575 (0.402 to 0.747) |
The effect of adding bevacizumab to preoperative chemotherapy comprised of cisplatin, doxorubicin, and HDMTX on the histologic response in patients with localized resectable osteosarcoma compared to historical controls treated with preoperative cisplatin, doxorubicin, and HDMTX without bevacizumab on the Intergroup Study 0133. Histologic response at week 10 of therapy was evaluated by Huvos grading systems as grade I: tumor not responding to therapy, no effect identified; grade IIA: more than 50% viable tumor left; grade IIB: 5-50% viable tumor remaining; grade III: only scattered foci of viable tumor seen (less than 5% of tumor); grade IV: no viable tumor seen in extensive sampling (at least a full cross-section of the tumor). The study did not enroll an adequate number of participants, therefore, the comparison to Intergroup Study 0133 participants was not done.
| participants | A: Localized Resectable Disease | C: Metastatic Tumors |
|---|---|---|
| Grade I | 1 | 0 |
| Grade IIA | 5 | 1 |
| Grade IIB | 17 | 7 |
| Grade III | 8 | 3 |
Kaplan-Meier method was used to estimate the EFS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.
| probability | All Participants |
|---|---|
| 2-Year Event Free Survival (EFS) of Patients With Osteosarcoma | 0.617 (0.470 to 0.764) |
Kaplan-Meier method was used to estimate the OS of patients with osteosarcoma treated with chemotherapy and Bevacizumab.
| probability | All Participants |
|---|---|
| 2-Year Overall Survival (OS) of Patients With Osteosarcoma | 0.880 (0.782 to 0.978) |
The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS20008 to that of OS99 (NCT00145639) participants was not done. The 2-year EFS of OS2008 participants is reported here.
| probability | A: Localized Resectable Disease |
|---|---|
| 2-Year Event Free Survival (EFS) in Patients With Localized Resectable Disease Compared to St. Jude OS99 Protocol. | 0.642 (0.473 to 0.810) |
The current protocol OS2008 (NCT00667342) was closed early due to slow accrual. Thus, with the limited number of patients, the comparison of EFS of OS2008 to that of OS99 (NCT00145639) participants was not done. The 2-year OS of OS2008 participants is reported here.
| probability | A: Localized Resectable Disease |
|---|---|
| 2-Year Overall Survival (OS) in Patients With Localized Resectable Disease Compared to OS99 Protocol. | 0.934 (0.847 to 1.0) |
The volume transfer constant (Ktrans) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.
| min(-1) | A: Localized Resectable Disease | C: Metastatic Tumors |
|---|---|---|
| Baseline | 0.13 ± 0.04 | 0.15 ± 0.07 |
| Day -2 | 0.11 ± 0.05 | 0.14 ± 0.03 |
| Day 1 | 0.12 ± 0.06 | 0.16 ± 0.04 |
| Day 5 | 0.14 ± 0.06 | 0.16 ± 0.04 |
| Week 5 | 0.08 ± 0.04 | 0.10 ± 0.05 |
| Week 10 | 0.07 ± 0.05 | 0.07 ± 0.03 |
The fractional blood plasma volume (Vp) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.
| (unitless) | A: Localized Resectable Disease | C: Metastatic Tumors |
|---|---|---|
| Baseline | 0.0081 ± 0.0024 | 0.0094 ± 0.0016 |
| Day -2 | 0.0067 ± 0.0020 | 0.0077 ± 0.0022 |
| Day 1 | 0.0070 ± 0.0027 | 0.0095 ± 0.0027 |
| Day 5 | 0.0066 ± 0.0033 | 0.0089 ± 0.0029 |
| Week 5 | 0.0063 ± 0.0029 | 0.0069 ± 0.0032 |
| Week 10 | 0.0060 ± 0.0044 | 0.0055 ± 0.0026 |
The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.
| (unitless) | A: Localized Resectable Disease | C: Metastatic Tumors |
|---|---|---|
| Baseline | 0.2543 ± 0.0785 | 0.2671 ± 0.0888 |
| Day -2 | 0.2444 ± 0.0871 | 0.2623 ± 0.0781 |
| Day 1 | 0.2564 ± 0.1209 | 0.2602 ± 0.0447 |
| Day 5 | 0.2854 ± 0.1138 | 0.3126 ± 0.0727 |
| Week 5 | 0.3055 ± 0.1622 | 0.3105 ± 0.1425 |
| Week 10 | 0.2776 ± 0.1225 | 0.2726 ± 0.1596 |
The association of interested variables with response was checked with the Wilcoxon rank-sum test. The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.
| Participants | All Participants |
|---|---|
| Poor Response | 22 |
| Good Response | 18 |
The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.
| min(-1) | All Participants |
|---|---|
| Poor Response | 0.0775 ± 0.0089 |
| Good Response | 0.0491 ± 0.0053 |
The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%. P95 denotes the level of each kinetic parameter exceeding 95% of its values in each tumor.
| min(-1) | All Participants |
|---|---|
| Poor Response | 0.2047 ± 0.0224 |
| Good Response | 0.1228 ± 0.0136 |
The response is based on the Huvos grade of histologic response for DCE-MRI comparisons and is defined as good for ≥90% necrosis and poor for less than 90%.
| (unitless) | All Participants |
|---|---|
| Poor Response | 6.2894 ± 0.9303 |
| Good Response | 3.2720 ± 0.3814 |
Of the 43 participants enrolled on this trial, 37 met criteria for evaluation of neuropathic pain (NP) following definitive surgery. The 37 participants underwent 38 surgeries: one participant had a limb-sparing surgery followed by an amputation surgery. Six of 43 participants were excluded from evaluation for NP: 1 due to deep vein thrombosis, 2 removed from study prior to surgery, 1 removed immediately after surgery to receive radiation therapy, 1 had non-extremity osteosarcoma, and 1 patient had a fibula resection. Patients were followed for neuropathic pain daily for the first week postoperatively and weekly for up to 6 months postoperatively.
| participants | Amputation Group | Limb Sparing Group | Entire Study Group |
|---|---|---|---|
| Number of Participants With Neuropathic Pain (NP) Following Surgery | 10 | 20 | 30 |
Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.
| Weeks | Amputation Group | Limb Sparing Group | Entire Study Group |
|---|---|---|---|
| Median Duration of Neuropathic Pain | 3.5 (0.9 to 12.9) | 4.9 (0.3 to 29.9) | 4.4 (0.3 to 29.9) |
Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.
| Weeks | Amputation Group | Limb Sparing Group | Entire Study Group |
|---|---|---|---|
| Mean Duration of Neuropathic Pain | 4.9 ± 4.0 | 7.2 ± 8.4 | 6.5 ± 7.2 |
Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain (NP). Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.
| Weeks | Amputation Group | Limb Sparing Group | Entire Study Group |
|---|---|---|---|
| Median Duration of Neuropathic Pain Medication | 6.5 (3.0 to 30.0) | 7.0 (1.7 to 29.9) | 7.0 (1.7 to 30.0) |
Thirty participants who underwent surgery (31 surgeries) were determined to have neuropathic pain. Four participants received only opioids for NP and 26 participants (for 27 surgeries) were treated with NP specific medications including gabapentin, tricyclic antidepressant, methadone. One participant had 2 different surgical procedures and was analyzed both in the limb sparing group and in the amputation group.
| Weeks | Amputation Group | Limb Sparing Group | Entire Study Group |
|---|---|---|---|
| Mean Duration of Neuropathic Pain Medication | 9.0 ± 8.0 | 9.8 ± 8.4 | 9.5 ± 8.1 |
Collected over Adverse events were recorded from on-study date through April 2015.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A: Localized Resectable Disease | — | 3/31 (9.7%) | 31/31 (100%) |
| C: Metastatic Tumors | — | 0/11 (0%) | 11/11 (100%) |
| Event | A: Localized Resectable Disease | C: Metastatic Tumors |
|---|---|---|
| HypotensionCardiac disorders | 1/31 | 0/11 |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)General disorders | 1/31 | 0/11 |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)Infections and infestations | 1/31 | 0/11 |
| Cognitive disturbanceNervous system disorders | 1/31 | 0/11 |
| EncephalopathyNervous system disorders | 1/31 | 0/11 |
| Neuropathy: motorNervous system disorders | 1/31 | 0/11 |
| Neuropathy: sensoryNervous system disorders | 1/31 | 0/11 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/31 | 0/11 |
| Event | A: Localized Resectable Disease | C: Metastatic Tumors |
|---|---|---|
| HemoglobinBlood and lymphatic system disorders | 30/31 | 11/11 |
| Leukocytes (total WBC)Blood and lymphatic system disorders | 30/31 | 11/11 |
| PlateletsBlood and lymphatic system disorders | 30/31 | 11/11 |
| ProteinuriaMetabolism and nutrition disorders | 20/31 | 11/11 |
| Neutrophils/granulocytes (ANC/AGC)Blood and lymphatic system disorders | 31/31 | 11/11 |
| ALT, SGPT (serum glutamic pyruvic transaminase)Metabolism and nutrition disorders | 29/31 | 10/11 |
| Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders | 29/31 | 10/11 |
| AST, SGOT (serum glutamic oxaloacetic transaminase)Metabolism and nutrition disorders | 29/31 | 10/11 |
| Potassium, serum-low (hypokalemia)Metabolism and nutrition disorders | 21/31 | 10/11 |
| Phosphate, serum-low (hypophosphatemia)Metabolism and nutrition disorders | 26/31 | 9/11 |
Participants were eligible if they were ≤30 years of age on date of diagnostic biopsy confirmation of high-grade osteosarcoma or malignant fibrous histiocytoma (MFH) of bone. Participants had no previous chemotherapy or radiation therapy.
| Age, Continuous(years) | A: Localized Resectable Disease | B: Localized Unresectable Disease | C: Metastatic Tumors | Total |
|---|---|---|---|---|
| Mean | 12.7 ± 3.5 | — | 13.3 ± 4.2 | 12.9 ± 3.6 |
| Age, Continuous(years) | A: Localized Resectable Disease | B: Localized Unresectable Disease | C: Metastatic Tumors | Total |
|---|---|---|---|---|
| Median | 12 (6 to 20) | — | 12 (8 to 20) | 12 (6 to 20) |
| Sex: Female, Male(Participants) | A: Localized Resectable Disease | B: Localized Unresectable Disease | C: Metastatic Tumors | Total |
|---|---|---|---|---|
| Female | 15 | — | 5 | 20 |
| Male | 16 | — | 7 | 23 |
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