A Phase 2 interventional study of Irinotecan and Vincristine in Bone Cancer and Ewing's Sarcoma, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by Stanford University · Phase 2, Interventional, and Treatment
The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 3 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Regimen A alternating with Regimen B every 21 days Regimen A: * Cytoxan 1200mg/m2 * Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2 * Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg * Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle Regimen B: * Irinotecan 50 mg/m2/day x 5 days * Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Drug: Irinotecan · Drug: Vincristine · Drug: Temozolomide · Drug: Doxorubicin · Drug: Cytoxan · Drug: Pegfilgrastim
50 mg/m2/day x 5 days
Also known as: Camptosar, Campto
2 mg/m2 to a maximum of 2 mg
Also known as: Oncovin, leurocristine
100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Also known as: Temodar, Temodal
Starting dose 75 mg/m2 to a maximum of 450mg/m2
Also known as: Adriamycin, hydroxydaunorubicin
1200 mg/m2
Also known as: Cyclophosphamide, Endoxan, Neosar, Procytox, Revimmune, cytophosphane
6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle
Also known as: Neulasta
Overall Response Rate (Partial and Complete Response)
Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy. Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.
Time frame: Up to 24 months
Progression-free Survival (PFS)
The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.
Time frame: 24 months
| Milestone | Combination Therapy |
|---|---|
| Started | 3 |
| Completed | 2 |
| Not completed | 1 |
| Withdrew: Per insurance pvdr, pt can't be on cl tr | 1 |
Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy. Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.
| Participants | Combination Therapy |
|---|---|
| Complete Response | 0 |
| Partial Response | 2 |
The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.
No measurements were reported for this outcome.
Collected over All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combination Therapy | — | 1/3 (33.3%) | 3/3 (100%) |
| Event | Combination Therapy |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/3 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/3 |
| DiarrheaGastrointestinal disorders | 1/3 |
| DehydrationGeneral disorders | 1/3 |
| FeverGeneral disorders | 1/3 |
| Event | Combination Therapy |
|---|---|
| Mucositis oral G1Gastrointestinal disorders | 2/3 |
| Diarrhea G1Gastrointestinal disorders | 2/3 |
| Intermittent headache G1General disorders | 1/3 |
| Decreased energy G1Gastrointestinal disorders | 1/3 |
| Fatigue G1Gastrointestinal disorders | 1/3 |
| Insomnia G1General disorders | 1/3 |
| Insomnia G2General disorders | 1/3 |
| Fever G1General disorders | 1/3 |
| Hiccups G1General disorders | 1/3 |
| Throat pain G2Gastrointestinal disorders | 1/3 |
| Age, Categorical(Participants) | Combination Therapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Combination Therapy |
|---|---|
| Female | 1 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Combination Therapy |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Combination Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Combination Therapy |
|---|---|
| United States | 3 |
Plan to share: No
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This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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