Overview

Bryostatin 1 Plus Paclitaxel and Cisplatin in Treating Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
2001-10-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy with bryostatin 1 plus paclitaxel and cisplatin in treating patients with advanced solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Bryostatin 1
Cisplatin
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor Must be refractory
to standard therapy or no standard therapy exists No CNS metastases or CNS primary
malignancy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count
at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than
1.5 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine
no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No
history of cardiac arrhythmias No congestive heart failure No myocardial infarction in the
last 6 months Neurologic: No grade 3 or greater neurotoxicity Other: HIV negative No
serious or uncontrolled infection Not pregnant Adequate contraception required of all
fertile patients during study and until 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered Chemotherapy: At least 6 weeks since prior nitrosoureas or mitomycin At least 4
weeks since other prior chemotherapy Must have recovered from prior chemotherapy Endocrine
therapy: Must have recovered from prior endocrine therapy Radiotherapy: At least 4 weeks
since prior radiotherapy and recovered Surgery: Not specified