O(6)-Benzylguanine and Carmustine in Treating Patients With Solid Tumors

NCT00002604 | Completed Phase 1 DMC

• 4 other identifiers: CWRU1994U01CA062502CWRU-ICC-1994NCI-T94-0022D
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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 O(6)-benzylguanine and carmustine in treating patients who have solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• dose escalation study of 06-benzylguanine (BG) and carmustine (BCNU)

  Courses (each course is 3 weeks) repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of BG until the biochemical modulation dose l (BMDl) is determined.

Interventions

O6-benzylguanine DRUG

Patients receive BG IV over 1 hour during week 1, and then BG IV over 1 hour during week 3. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

carmustine DRUG

After one hour of receiving BG patients receive BCNU IV over 1 hour during week 3. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Also known as: BCNU

chemosensitization/potentiation therapy DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed solid tumor for which no standard treatment exists (including surgery, radiotherapy, or systemic agents) No primary CNS malignancy No CNS metastases Only disease that can be sequentially biopsied is eligible for determination of the biochemical modulating dose that decreases AGT in tumor tissue PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Hematopoietic: WBC greater than 4,000/mm3 Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Prothrombin time less than upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium normal Electrolytes normal Other: Diabetes controlled by diet or insulin allowed Not pregnant Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since mitomycin) and recovered No prior nitrosoureas Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

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

Cleveland, Ohio, 44106-5065, United States

Location

Veterans Affairs Medical Center - Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

O(6)-benzylguanine; Carmustine

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• James KV Willson, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 29, 2004
• Study Start: January 1, 1996
• Primary Completion: July 1, 2000
• Study Completion: February 1, 2004
• Last Updated: July 8, 2010

Record last verified: 2010-07

Locations

US (2)