O6-benzylguanine and Carmustine in Treating Patients With Unresectable Locally Recurrent or Metastatic Melanoma

NCT00005961 | Completed Phase 2

• 5 other identifiers: NCI-2012-02340UCCRC-10325CWRU-1699NCI-T99-0111CDR0000067943
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 13

Brief Summary

Phase II trial to study the effectiveness of O6-benzylguanine and carmustine in treating patients who have unresectable locally recurrent or metastatic melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than once chemotherapy drug may kill more tumor cells.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV over 1 hour on day 1. Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.

Drug: O6-benzylguanine; Drug: carmustine

Interventions

O6-benzylguanine DRUG

Arm I

carmustine DRUG

Arm I

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven unresectable locally recurrent or metastatic melanoma * Chemotherapy naive with no more than 2 prior immunotherapy regimens (including cytokines, vaccines, or adjuvant interferon) OR * Prior chemotherapy failure with no more than 2 prior immunotherapy regimens (including adjuvant interferon) and no more than 1 prior chemotherapy regimen (which may include carmustine) not including antiangiogenesis therapy * Measurable disease * At least 20 mm in at least 1 dimension by conventional technique OR at least 10 mm in at least 1 dimension by spiral CT scan * No disease confined only to the CNS * No uncontrolled symptomatic brain metastases regardless of other disease sites PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST and/or ALT no greater than 3 times upper limit of normal * PT normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Pulmonary: * DLCO at least 70% predicted Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent significant psychiatric or medical illness, including active infections, that would interfere with study therapy or increase risk * No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer PRIOR CONCURRENT THERAPY: Chemotherapy: * At least 4 weeks since prior systemic chemotherapy (at least 6 weeks since prior carmustine or mitomycin) and recovered * No other concurrent chemotherapy or investigational antineoplastic drugs Radiotherapy: * At least 2 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * At least 3 weeks since prior major surgery and recovered Other: * At least 4 weeks since other prior anticancer systemic therapy and recovered

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (13)

University of Illinois at Chicago Health Sciences Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Incorporated

Fort Wayne, Indiana, 46885-5099, United States

Location

Michiana Hematology/Oncology P.C.

South Bend, Indiana, 46617, United States

Location

Mercy Ireland Cancer Center

Canton, Ohio, 44708, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

O(6)-benzylguanine; Carmustine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Thomas F. Gajewski, MD, PhD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: June 1, 2000
• Primary Completion: December 1, 2005
• Last Updated: February 11, 2013

Record last verified: 2003-04

Locations

US (13)