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O6-Benzylguanine and Carmustine in Treating Patients With Unresectable Locally Recurrent or Metastatic Melanoma
This study has been completed.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005961
  Purpose

RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of O6-benzylguanine and carmustine in treating patients who have unresectable locally recurrent or metastatic melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: O6-benzylguanine
Drug: carmustine
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: O(6)-Benzylguanine Carmustine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Metatstatic Melanoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

OBJECTIVES:

  • Determine the objective clinical response rate and duration of response in patients with unresectable locally recurrent or metastatic melanoma treated with O6-benzylguanine and carmustine.
  • Compare the toxicities of this regimen in patients with no prior chemotherapy vs prior chemotherapy failure.
  • Correlate clinical response to this regimen in these patients with O6-alkylguanine DNA alkyltransferase (AGT) depletion and baseline AGT in peripheral blood mononuclear cells and tumor tissue.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (chemotherapy failure vs chemotherapy naive).

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.

Patients with disease progression are followed every 6 months. All other patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 24-41 patients will be accrued for the chemotherapy failure stratum and a total of 18-35 patients will be accrued for the chemotherapy naive stratum of this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics
  • 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

Endocrine therapy:

  • Not specified

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005961

Locations
United States, Illinois
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Health Care
Evanston, Illinois, United States, 60201
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States, 46617
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Mercy Ireland Cancer Center
Canton, Ohio, United States, 44708
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067943, UCCRC-10325, CWRU-1699, NCI-T99-0111
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005961     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Carmustine
Neuroepithelioma
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Nevus
Alkylating Agents
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Carmustine
Enzyme Inhibitors
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
O(6)-benzylguanine
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on May 07, 2009