Phase II Study of Penicillamine and Reduction of Copper for Angiosuppressive Therapy of Adults With Newly Diagnosed Glioblastoma
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Study of Penicillamine and Reduction of Copper for Angiosuppressive Therapy of Adults With Newly Diagnosed Glioblastoma
OBJECTIVES: I. Determine the effect of penicillamine and copper reduction on survival and
time to progression in adults with newly diagnosed glioblastoma. II. Determine the effect of
penicillamine on the reduction of serum copper in these patients. III. Determine whether
penicillamine reduces the tumor volume, vascularity, invasion, and edema in these patients.
OUTLINE: Patients receive oral penicillamine on the following schedule: Week 1: once daily
Week 2: two times daily Week 3: three times daily Week 4: four times daily Week 5 to end of
study: increased dose four times daily. Patients also receive oral pyridoxine daily and
maintain a low copper diet (no greater than 0.5 mg/day). This regimen is continued for up to
2 years in the absence of disease progression or unacceptable toxicity. Radiotherapy is
administered over 6 weeks, beginning on day 1 of penicillamine therapy. Patients are
followed every month (with MRI every 2 months) until death.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven supratentorial grade IV astrocytoma
(glioblastoma multiforme)
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 2 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil
count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10.0 g/dL
No serious blood dyscrasias Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT no
greater than 4 times upper limit of normal (ULN) Albumin at least 3.0 g/dL PT and PTT no
greater than 1.5 times ULN No liver failure Renal: Creatinine no greater than 1.7 mg/dL OR
BUN no greater than 40 mg/dL No renal failure Other: Not pregnant or nursing Fertile
patients must use effective contraception No serious infection No concurrent serious
medical illness No allergy to penicillin or history of serious reaction to penicillamine
No prior malignancy within the past 5 years except curatively treated carcinoma in situ or
basal cell skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for brain tumor No
prior biologic therapy for brain tumor, including: Immunotoxins Immunoconjugates Antisense
Peptide receptor antagonists Interferons Interleukins Tumor infiltrating lymphocytes
Lymphokine activated killer cells Gene therapy No concurrent growth factors (e.g.,
filgrastim or epoetin alfa) Chemotherapy: No prior chemotherapy for brain tumor Endocrine
therapy: Must be on stable corticosteroid regimen for at least 1 week (at least 5 days) No
other prior hormonal therapy for brain tumor Radiotherapy: No prior radiotherapy for brain
tumor Surgery: Recovered from prior surgery Other: No concurrent investigational agents No
concurrent gold compounds (auronofin, gold sodium thiomalate) No concurrent herbal dietary
supplements
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Steven Brem, MD
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
NABTT-9704 CDR0000066872
NCT ID:
NCT00003751
Start Date:
March 1999
Completion Date:
July 2005
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157-1082 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Emory University School of Medicine | Atlanta, Georgia 30322 |
