Phase II Study of Gamma Knife Radiosurgery and Temozolomide for Brain Metastases

NCT00582075 | Completed Phase 2 Results DMC

• 1 other identifier: F020522015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The protocol is designed to determine the efficacy of temozolomide in preventing the development of new brain metastases within the first year in patients undergoing stereotactic radiation for newly diagnosed brain metastases.

Conditions

Cancer; Brain Metastases

Keywords

Cancer; Brain metastases; Gamma Knife Radiosurgery; Temodar; Temozolomide

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Distant Brain Failure (DBF) at One Year

  Patients developing distant brain failure (DBF) at one year. An approximation method was used to arrive at the reported percentage.

  1 years

Secondary Outcomes (1)

• Overall Survival

  2 years

Study Arms (1)

Radiosurgery 15-24 Gy + Adjuvant Temozolomide

EXPERIMENTAL

Drug: temozolomide

Interventions

temozolomide DRUG

TMZ 200mg/m2 days 1-5 repeat q28 days. Patients who have received prior chemotherapy will receive 150 mg/m2 days 1-5

Also known as: Temodar

Radiosurgery 15-24 Gy + Adjuvant Temozolomide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must have history of histologically confirmed malignancy. Brain biopsy is not required unless diagnosis is judged to be in doubt by the treating physician.
• Newly diagnosed brain metastases (four or fewer by thin slice post-contrast MRI).
• ECOG performance status of less than or equal to 2 for patients with no prior chemotherapy, and less than or equal to 1 for patients with prior chemotherapy.
• Age greater than 18
• Life expectancy greater than 12 weeks
• Subjects given written informed consent
• Adequate hematologic, renal and liver function as demonstrated by laboratory values performed within 14 days, inclusive, prior to administration of study drug:
• Absolute neutrophil count (ANC) \>= 1500/mm3
• Platelet count \>= 100,000/mm3
• Hemoglobin \>= 9 g/dL
• BUN and serum creatinine \<= 1.5 times upper limit of laboratory normal
• Total and direct bilirubin \<= 2 times upper limit of laboratory normal or in the presence of documented liver metastases, total and direct bilirubin \<=5 times upper limit of normal
• SGOT and SGPT \<= 2 times upper limit of laboratory normal or in the presence of documented liver metastases, SGOT and SGPT \<=5 times upper limit of normal
• Alkaline phosphatase \<= 2 times upper limit of laboratory normal or in the presence of documented liver metastases, alkaline phosphatase of \<= 5 times upper limit of normal

You may not qualify if:

• Patients with small cell lung cancer and lymphoma are ineligible.
• More than four metastases by thin slice MRI. Note that if a diagnostic study prior to radiosurgery demonstrates only four tumors but the gamma knife treatment-planning scan reveals greater than four tumors, the patients will still be eligible for the protocol if all tumors can be treated with radiosurgery.
• Chemotherapy within four weeks prior to study drug administration
• Patients, who in the opinion of the treating medical oncologist, require immediate cytotoxic chemotherapy other than the study drug. Allowed medications include antihormonal agents (i.e., Tamoxifen), herceptin and bisphosphonates.
• Radiation therapy to greater than or equal to 50% of the bone marrow. Completion of radiation therapy less than 4 weeks prior to study drug administration for radiotherapy to \>= 15% of bone marrow and less than 2 weeks prior for radiotherapy to \< 15% of bone marrow.
• Insufficient recovery from all active toxicities of prior therapies
• Subjects who are poor medical risks because of non-malignant systemic disease
• Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction).
• Previous or concurrent malignancies at other sites, or treatment for malignancy at the site within 5 years of study start with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
• Known HIV positively or AIDS-related illness.
• Pregnant or nursing women.
• Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
• Men who are not advised to use an effective method of contraception.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Integrated Therapeutics Group: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

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  RESULT

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John Fiveash, MD
• Organization: University of Alabama at Birmingham

jfiveash@uabmc.edu

205-975-0224

Study Officials

• John Fiveash, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 28, 2007
• Study Start: July 1, 2002
• Primary Completion: October 1, 2008
• Study Completion: June 1, 2015
• Last Updated: March 27, 2023
• Results First Posted: September 17, 2015

Record last verified: 2023-03

Locations

US (1)