Know Cancer

or
forgot password

PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA


OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 72-hour continuous
infusion in patients with relapsed multiple myeloma. II. Determine the qualitative and
quantitative toxic effects of bryostatin 1 in these patients. III. Determine the duration of
response and survival following bryostatin 1 in these patients.

OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks
until disease progression or 2 courses beyond complete remission. Response is assessed after
every 4 courses. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 15-25 evaluable patients will be entered into this study over
1.25 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ayad M. Al-Katib, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000065272

NCT ID:

NCT00002907

Start Date:

January 1997

Completion Date:

November 2000

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201