Overview
Bryostatin 1 in Treating Patients With Relapsed Multiple Myeloma
Status:
Completed
Completed
Trial end date:
2000-11-01
2000-11-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Barbara Ann Karmanos Cancer InstituteCollaborator:
National Cancer Institute (NCI)Treatments:
Bryostatin 1
Criteria
DISEASE CHARACTERISTICS: Multiple myeloma of any stage that has failed 1 or 2 priorregimens (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