A Phase 1 interventional study of R-(-)-gossypol acetic acid and paclitaxel in Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma and Contiguous Stage II Adult Burkitt Lymphoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
This phase I trial is studying the side effects and best dose of gossypol when given together with paclitaxel and carboplatin in treating patients with solid tumors that are metastatic or cannot be removed by surgery. Drugs used in chemotherapy, such as gossypol, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gossypol together with paclitaxel and carboplatin may kill more tumor cells
PRIMARY OBJECTIVES:
I. The primary end point will be to determine the maximum tolerated dose of AT-101 with paclitaxel and carboplatin.
SECONDARY OBJECTIVES:
I. To describe the toxicities associated with the combination of paclitaxel, carboplatin, and AT-101.
II. To evaluate the human pharmacokinetic disposition of AT-101 in the context of escalating doses.
III. To describe the pharmacokinetics of paclitaxel when given concurrently with AT-101.
IV. To evaluate for evidence of activity for the combination of paclitaxel, carboplatin and AT-101.
OUTLINE: This is a dose-escalation study of R-(-)-gossypol acetic acid.
Patients receive oral R-(-)-gossypol acetic acid twice daily on days 1-3. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacokinetic and pharmacodynamic studies by liquid chromatography/mass spectrometry.
After completion of study therapy, patients are followed for 4 weeks.
392 studies on the registry are indexed under Burkitt Lymphoma; 114 are open to participants now.
This study's enrollment of 36 is below the median of 41 across 354 interventional studies indexed under Burkitt Lymphoma.
Browse Burkitt Lymphoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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Exclusion Criteria:
Patients receive oral R-(-)-gossypol acetic acid twice daily on days 1-3. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Drug: R-(-)-gossypol acetic acid · Drug: paclitaxel · Drug: carboplatin · Other: pharmacological study
Given orally
Also known as: AT-101
Given IV
Also known as: Anzatax, Asotax, TAX, Taxol
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Correlative studies
Also known as: pharmacological studies
MTD, defined as the highest dose level below the maximally administered dose at which no more than 1 out of 6 patients experience DLT graded according to NCI CTCAE version 4.0
Time frame: Up to 21 days
AT-101 level (bound and unbound)
Samples will be analyzed by validated LC-MS techniques.
Time frame: Up to 4 weeks after completion of study treatment
Paclitaxel level (bound and unbound)
Samples will be analyzed by validated LC-MS techniques.
Time frame: Up to 4 weeks after completion of study treatment
Pharmacokinetics of AT-101
Pharmacokinetics will be determined by standard two-stage approaches using non-compartmental and compartmental modeling.
Time frame: Day 1 of courses 1 and 2 pre-AT-101 treatment and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, and 24 hours after AT-101 administration
Pharmacokinetics of paclitaxel
Pharmacokinetics will be determined by standard two-stage approaches using non-compartmental and compartmental modeling.
Time frame: Day 1 of courses 1 and 2 pre-AT-101 treatment and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 8, 10, and 24 hours after AT-101 administration
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)