BMS-247550 in Treating Patients With Advanced Cancers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant solid tumor or lymphoma for which no other potentially curative therapeutic option exists or demonstrates increased survival (considering tumor type, stage, and number of prior regimens)

• No symptomatic brain metastases requiring dexamethasone

• No progression or cerebral edema on CT scan or MRI within the past 4 weeks

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Neutrophil count at least 1,500/mm^3

• Hemoglobin at least 8.5 g/dL

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

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No atrial or ventricular arrhythmias requiring medication

• No ischemic event within the past 6 months

Other:

• No pre-existing peripheral neuropathy greater than grade 1

• No other serious medical illness or active infection that would preclude study participation

• No dementia, psychiatric illness, or other alteration in mental status that would preclude study compliance

• No other active malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

• No history of allergy or hypersensitivity reaction to paclitaxel or other Cremophor EL-containing compound

• Not pregnant or nursing

• Negative pregnancy test

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

• No other concurrent chemotherapy

Endocrine therapy:

• At least 4 weeks since prior anticancer hormonal therapy and recovered

• No concurrent hormonal therapy except LHRH agonists for non-castrated prostate cancer, contraceptives, hormone replacement therapy (e.g., conjugated estrogens), or megestrol as an appetite stimulant

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

• Concurrent palliative radiotherapy to limited sites allowed

Surgery:

• At least 4 weeks since prior surgery and recovered

Other:

• At least 30 days since prior investigational agents and recovered

• No other concurrent experimental medications

• No concurrent antiretroviral (HAART) therapy for HIV-positive patients