Completed

Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma

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What is being tested

O6-benzylguanine

+ carmustine

Drug
Who is being recruted

Blood Protein Disorders+12

+ Cardiovascular Diseases

+ Hematologic Diseases

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1999
See protocol details

Summary

Principal SponsorCase Comprehensive Cancer Center
Last updated: June 11, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma. Assess the effects of O6-benzylguanine on bone marrow myeloma cells in this patient population. OUTLINE: Patients receive O6-benzylguanine IV over 60 minutes followed 1 hour later by carmustine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response (partial or complete response or stable or plateau disease). Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

NCT00004072
Principal SponsorCase Comprehensive Cancer Center
Last updated: June 11, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeParaproteinemiasVascular DiseasesHemostatic DisordersMultiple MyelomaNeoplasms, Plasma Cell

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed progressive multiple myeloma, meeting 1 of the following criteria: Previously untreated Primary refractory Relapsing disease Major criteria: Plasmacytomas on tissue biopsy Bone marrow plasmacytosis with greater than 30% plasma cells Monoclonal globulin spike on serum electrophoresis Greater than 3.5 g/dL for G peaks or greater than 2.0 g for A peaks Greater than 1.0 g/24 hours of kappa or lambda light chain excretion on urine electrophoresis in the absence of amyloidosis Minor criteria: 10%-30% bone marrow plasmacytosis (criterion A) Presence of monoclonal globulin spike but less than the levels under major criteria (criterion B) Lytic bone lesions (criterion C) IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL (criterion D) Must meet one of the following: A minimum of 1 major criterion and 1 minor criterion 3 minor criteria, including criteria A and B PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,000/mm^3 Platelet count greater than 100,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Hemoglobin greater than 9 g/dL (transfusions allowed) Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Calcium less than 14 mg/dL Pulmonary: No prior or concurrent active, symptomatic respiratory disease Corrected DLCO at least 60% predicted Other: Controlled diabetes mellitus allowed Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen containing an alkylating agent for multiple myeloma At least 4 weeks since prior chemotherapy Endocrine therapy: Prior corticosteroids for multiple myeloma allowed Radiotherapy: No prior pelvic radiotherapy or radiotherapy to more than 25% of bone marrow Surgery: Not specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

University of Chicago Cancer Research Center

Chicago, United StatesOpen University of Chicago Cancer Research Center in Google Maps

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, United States

MetroHealth Medical Center

Cleveland, United States
Completed3 Study Centers