Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically diagnosed solid tumor (i.e., breast and ovarian epithelial carcinomas) or lymphoma.

• - Slides reviewed at the NCI Laboratory of Pathology.

• - Failure on therapy of proven efficacy for the disease.

• - Prior therapy not required for the following metastatic diseases: - Melanoma.

• - Non-small cell lung cancer.

• - Renal cell carcinoma.

• - No brain metastases.

• - Primary brain tumors (such as glioblastoma multiforme) with stable neurologic deficits allowed.

• - Measurable or evaluable disease required.

• - Demonstrated by physical exam or on radiograph within 2 weeks prior to initiation of treatment OR.

• - Elevated PSA associated with prostate cancer.

• - Other marker-only disease ineligible.

PATIENT CHARACTERISTICS: Age:

• - Over 18.

Performance status:

• - ECOG 0-2.

Life expectancy:

• - At least 3 months.

Hematopoietic:

• - WBC at least 3,000/mm^3.

• - Platelet count at least 100,000/mm^3.

• - Hematocrit at least 27% Hepatic: - Liver function tests no greater than 2 times upper limit of normal.

• - Bilirubin normal.

• - PT or PTT no greater than 1.25 times upper limit of normal.

• - Clotting parameters normal.

• - No concurrent anticoagulants other than 1 mg of warfarin per day for prophylaxis.

Renal:

• - Creatinine no greater than 1.5 mg/dL OR.

• - Creatinine clearance at least 45 mL/min.

• - No kidney obstruction.

Cardiovascular:

• - No cardiac conduction defect requiring antiarrhythmics.

• - No evidence of myocardial infarction or other myocardial damage within past 6 months.

Other:

• - HIV negative.

• - No concurrent infection.

• - No guaiac-positive stool test.

• - No neuropathy greater than grade I (unless associated with fixed-deficit primary brain tumors) - Not pregnant or nursing.

• - Fertile patients must use effective contraception during and for 2 months after study.

PRIOR CONCURRENT THERAPY:

• - Recovery from prior therapy required.

Biologic therapy:

• - At least 4 weeks since prior biologic therapy.

Chemotherapy:

• - At least 4 weeks since prior chemotherapy (6 weeks since mitomycin, nitrosoureas, or carboplatin) - No progression on carboxyamidotriazole or paclitaxel.

• - At least 6 months between treatment and relapse.

Endocrine therapy:

• - At least 4 weeks since prior hormonal therapy.

• - No concurrent corticosteroids except as physiologic replacement.

Radiotherapy:

• - At least 4 weeks since prior radiotherapy.

Surgery:

• - Not specified.

Other:

• - At least 1 week since prior therapeutic antibiotics.

- Concurrent prophylactic antibiotics allowed except imidazole antifungals (e.g., ketoconazole, fluconazole) - No concurrent calcium channel blockers

OBJECTIVES:

• - Determine the maximum tolerated dose of paclitaxel when combined with carboxyamidotriazole in patients with advanced solid tumors or refractory lymphomas.

• - Determine the pharmacokinetics and toxicities of this regimen in these patients.

• - Identify diseases for which this combination appears active.

OUTLINE: This is a dose escalation study. Patients receive oral carboxyamidotriazole (CAI) daily with paclitaxel IV over 3 hours on day 8 and every 3 weeks thereafter. Course 1 is 28 days and all other subsequent courses are 21 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses of treatment. Sequential dose escalation of CAI is followed by sequential dose escalation of paclitaxel. Dose escalation in cohorts of 3 to 6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.