Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors
Intervention: penicillamine (Drug); radiation therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Steven Brem, MD, Study Chair, Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Summary
RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the
tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation
therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be
effective in treating glioblastoma.
PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and
radiation therapy in treating patients who have newly diagnosed glioblastoma.
Clinical Details
Official title: Phase II Study of Penicillamine and Reduction of Copper for Angiosuppressive Therapy of Adults With Newly Diagnosed Glioblastoma
Study design: Treatment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama 35294, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States
Emory University School of Medicine, Atlanta, Georgia 30322, United States
Johns Hopkins Oncology Center, Baltimore, Maryland 21287, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States
Henry Ford Hospital, Detroit, Michigan 48202, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157-1082, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 1999
Last updated: May 23, 2008
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