Dietary Methionine Restriction Plus Temozolomide for Recurrent GBM

NCT00508456 | Terminated Phase 1

• 1 other identifier: ID03-0066
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 1.To determine the safety, tolerability and efficacy of dietary methionine restriction for 7 days alternating with Temodar® (Temozolomide) given once a day for seven days and this repeated for up to one year in the treatment of patients with recurrent and/or progressive glioblastoma.
2. 2.To determine the short- and long-term toxicity of dietary methionine restriction combined with Temodar® in glioblastoma patients.
3. 3.To measure and correlate patients' tumor responses and progression-free survival with: serum methionine and peripheral blood lymphocyte methylation levels. In any patient undergoing surgery, to measure tumor alkylguanyl transferase (AGT) and methionine levels and compare to control specimens.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma Multiforme; Methionine Restriction; Hominex-2; Methionine Restriction Diet; Hominex-2 Amino Acid-Modified Medical Food; Temozolomide; Temodar

Outcome Measures

Primary Outcomes (1)

• Time to Disease Progression

  Time to progression measured from the first day of treatment until progression is documented.

  6 months (26 weeks)

Study Arms (1)

Hominex®-2 + Temodar®

EXPERIMENTAL

Dietary Methionine Restriction (Hominex®-2) Days 1-7 and 15-21 + Temodar® 150 mg/m\^2 orally Days 8-15

Drug: Temodar (Temozolomide); Dietary Supplement: Hominex-2

Interventions

Temodar (Temozolomide) DRUG

150 mg/m\^2 orally once a day for 7 consecutive days (days 8 through 15).

Hominex®-2 + Temodar®

Hominex-2 DIETARY_SUPPLEMENT

Methionine free diet during Days 1 - 7 and Days 15 - 21 by consuming only "shakes" containing Hominex-2®.

Also known as: Hominex-2® shakes, Methionine restriction diet, Hominex®-2 Amino Acid-Modified Medical Food

Hominex®-2 + Temodar®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven glioblastoma multiforme (GBM).
• Unequivocal evidence of tumor recurrence or progression by MRI (or CT brain if a patient can not undergo MRI). Radiotherapy (with or without radiosensitizing drugs) must have been completed in the past. The earliest a patient can be enrolled in this study after radiotherapy is 14 days. The scan done prior to study entry documenting progression will be reviewed by the primary investigator to document tumor volume changes to provide a gross assessment of growth rate.
• Patients may have had: a) no prior chemotherapy, b) 1 prior adjuvant chemotherapy, c) 1 prior adjuvant chemotherapy followed by 1 regimen for recurrent disease, or d) 1 or 2 prior chemotherapy regimens for recurrent or progressive tumor.
• All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
• Enrollment MRI or CT scan of the brain must be performed within 14 days of registration. Patients having undergone recent resection of recurrent or progressive tumor will be eligible for assessment of response as long as there is residual enhancing evaluable disease that is documented by appropriate neuroimaging and patients have recovered from the effects of surgery. Patients who after surgery have no residual enhancing disease will still be eligible for enrollment, but only assessable for time to progression, and not for response.
• Patients must have a life expectancy \> 8 weeks.
• Patients must have a Karnofsky performance status of \> or = 60 (Karnofsky Performance Scale).
• Patients must have recovered from the toxic effects of prior therapy and/or at least 2 weeks from vincristine, 6 weeks from nitrosoureas, and 3 weeks from procarbazine administration. Patients must have recovered from the toxic effects of any other cytotoxic drugs which they may have received and must be 1 week from the completion of any non-cytotoxic drug therapy (e.g. 13-cis-retinoic acid, thalidomide, tamoxifen, etc.). For those patients previously treated with temozolomide, they may enroll and start the diet even 1 day after their last temozolomide dose.
• Patients must have adequate bone marrow function (ANC\> or = 1,500/mm3 and platelet count of \> or = 100,000/mm3), adequate liver function (SGPT and alkaline phosphatase = or \<2 times normal, bilirubin = or \<1.5 mg%), and adequate renal function (BUN or creatinine = or \<1.5 times institutional normal) prior to starting therapy.
• All acute toxic effects (excluding neurotoxicity or alopecia) of any prior therapy must have resolved to Common Toxicity Criteria (CTC) grade = or \< 1.
• Patients who are eligible for the trial and who require resection of their tumor may begin the dietary restriction component of the therapy prior to their surgery providing the time to surgery is greater than 6 days. In these patients, tissue collected at surgery will be analysed for the effects of treatment. After surgery, patients will resume an ad lib diet for anywhere from 5-14 days prior to the re-initiation of the dietary methionine restriction at the same dose level and continuance with the trial.

You may not qualify if:

• Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
• Patients have one or more of the following conditions may not participate in this study: a) active infection; b) pregnancy and/or disagree to practice adequate contraception; c) disease that will obscure toxicity or dangerously alter drug metabolism; d) serious intercurrent medical illness.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Morris D. Groves, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 30, 2007
• Study Start: August 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 16, 2012

Record last verified: 2012-01

Locations

US (1)