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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00891072 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: R-(-)-gossypol acetic acid Drug: carboplatin Drug: paclitaxel Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 1 Study of R-(-)-Gossypol (Ascenta's AT-101) in Combination With Paclitaxel and Carboplatin in Solid Tumors |
Estimated Enrollment: | 36 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignancy
Previously treated brain metastases clinically and radiographically stable or improved ≥ 4 weeks after completion of radiation therapy and off steroids are allowed
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No more than 9 months of prior marrow-damaging cytotoxic chemotherapy including, but not limited to, platinum agents, cyclophosphamide, ifosfamide, carmustine, and mitomycin C
Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Mark Stein ) |
Study ID Numbers: | CDR0000640622, CINJ-050905, 0220090064 |
Study First Received: | April 29, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00891072 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific recurrent adult grade III lymphomatoid granulomatosis adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia contiguous stage II adult Burkitt lymphoma noncontiguous stage II adult Burkitt lymphoma recurrent adult Burkitt lymphoma stage I adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma recurrent adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma |
stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma recurrent adult diffuse mixed cell lymphoma stage I adult diffuse mixed cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma recurrent adult diffuse small cleaved cell lymphoma stage I adult diffuse small cleaved cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma |
Contraceptive Agents Lymphoma, Mantle-Cell Contraceptive Agents, Female Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Mantle Cell Lymphoma Contraceptive Agents, Male Lymphoblastic Lymphoma Lymphoma, T-Cell, Peripheral Follicular Lymphoma Gossypol Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia, Lymphocytic, Chronic, B-Cell |
Lymphoma, T-Cell Retinol acetate Lymphoma, Large-Cell, Immunoblastic Leukemia, B-cell, Chronic Lymphoma, Large-cell Lymphoma Peripheral T-cell Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Immunoproliferative Disorders Antimitotic Agents Carboplatin Gossypol acetic acid Recurrence Burkitt's Lymphoma |
Molecular Mechanisms of Pharmacological Action Contraceptive Agents Antineoplastic Agents Physiological Effects of Drugs Contraceptive Agents, Female Reproductive Control Agents Contraceptive Agents, Male Gossypol Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Antispermatogenic Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Mitosis Modulators Antimitotic Agents Carboplatin Gossypol acetic acid Pharmacologic Actions Lymphatic Diseases Neoplasms Paclitaxel Tubulin Modulators Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Spermatocidal Agents |