Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain

NCT00012116 | Completed Phase 2

• 4 other identifiers: CDR0000068485UCLA-0004059SPRI-UCLA-0004059NCI-G01-1919
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain.

Conditions

Metastatic Cancer

Keywords

tumors metastatic to brain

Outcome Measures

Primary Outcomes (1)

• To assess the rate of response/control of cerebral metastases from solid tumors to extended low dose, continuous oral temozolomide

  2 years

Secondary Outcomes (3)

• To assess the safety and tolerability of low dose, continuous oral temozolomide in this patient population

  2 years

• to measure quality of life in patients with cerebral metastases treated with low dose, continuous temozolomide

  2 years

• To measure the rate of response of systemic disease outside the central nervous system to extended low dose continuous oral temozolomide

  2 years

Study Arms (1)

temozolomide

EXPERIMENTAL

Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2.

Drug: temozolomide

Interventions

temozolomide DRUG

Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2.

Also known as: Temodar, Temodal

temozolomide

Eligibility Criteria

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

You may qualify if:

• Age greater than or equal to 18 years.
• Karnofsky performance status (KPS) of greater than or equal to 60.
• Laboratory values (performed within 14 days prior to study drug administration, inclusive).
• Absolute neutrophil count (ANC) \>1500/mm3
• Platelet count \>100,000/mm3
• Hemoglobin \>10 g/dl or 100 g/l
• BUN and serum creatinine \<1.5 times upper limit of laboratory normal
• Total and direct bilirubin \<1.5 times upper limit of laboratory normal
• SGOT and SGPT \< 3 times upper limit of laboratory normal
• Alkaline Phosphatase \< 3 times upper limit of laboratory normal
• A life expectancy from disease outside the CNS of greater than 12 weeks.
• Subjects must give written informed consent.
• Subjects must have histologically confirmed advanced solid malignancy with brain metastases, with or without systemic disease.
• Subjects must have failed or refused prior standard therapy for cerebral metastases and have imaging evidence of progressive disease. Prior therapy may include surgery and/or whole brain radiotherapy and/or stereotactic radiosurgery.
• At least 2 weeks must have elapsed since the completion of radiotherapy at any site other than brain, prior to start of study medication. At least 4 weeks must have elapsed since the completion of brain radiotherapy.

You may not qualify if:

• No recovery from all active toxicities of prior therapies (other than hair loss).
• Surgery within 1 week (inclusive) prior to study drug administration, otherwise may be eligible providing acute toxicity is resolved.
• Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
• Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction).
• Concurrent primary malignancies at other sites with the exception of surgically cured carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
• Known HIV positivity 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 do not agree to use an effective method of contraception.
• Chemotherapy (excluding nitrosurea, mitomycin C or vincristine), within four weeks, inclusive, prior to study drug administration; biologic therapy or immunotherapy within two weeks, inclusive, prior to study drug administration.
• Nitrosurea or mitomycin C administration within six weeks, inclusive, prior to study drug administration.
• Completion of radiation therapy to sites outside the brain or interstitial brachytherapy within 2 weeks prior to study drug administration.
• Known carcinomatous meningitis.
• Lymphoma.
• Planned radiation therapy to systemic site.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Schering-Plough: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Judith M. Ford, MD, PhD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2001
• First Posted: January 1, 2004
• Study Start: October 1, 2000
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: August 3, 2020

Record last verified: 2012-07

Locations

US (1)