Overview

Bryostatin 1 in Treating Patients With Relapsed Multiple Myeloma

Status:
Completed
Trial end date:
2000-11-01
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. PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with relapsed multiple myeloma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
Bryostatin 1
Criteria
DISEASE CHARACTERISTICS: Multiple myeloma of any stage that has failed 1 or 2 prior
regimens (chemotherapy, biologic therapy, or both, or bone marrow transplantation) Evidence
of disease progression required Ineligible for known treatment of higher potential efficacy
One of the following protein criteria required: Quantifiable M-components of IgG, IgA, IgD,
or IgE Urinary kappa or lambda light chain (Bence-Jones protein) excretion Re-treatment on
this protocol allowed if disease relapsed after a complete remission

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet
count greater than 50,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Transaminases less
than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance
at least 60 mL/min Cardiovascular: No history of impaired cardiac status, e.g.: Severe
coronary artery disease Cardiomyopathy Congestive heart failure Arrhythmia Other: No known
AIDS or HIV infection No second malignancy within 5 years except: Adequately treated
nonmelanomatous skin cancer Carcinoma in situ of the cervix No pregnant or nursing women
Effective contraception required of fertile patients during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics At least 4 weeks since chemotherapy (8 weeks since mitomycin or
nitrosoureas) and recovered Endocrine therapy: No concurrent steroids Radiotherapy: At
least 4 weeks since radiotherapy and recovered Surgery: Not specified