Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

NCT00026494 | Completed Phase 1 Results

• 3 other identifiers: 01-088MSKCC-01088ANCI-G01-2025
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide and vinorelbine in treating patients who have recurrent brain metastases.

Conditions

Metastatic Cancer

Keywords

tumors metastatic to brain

Outcome Measures

Primary Outcomes (1)

• Radiographic Response Assessed by Macdonald Criteria Every 2 Months

  All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.

  2 years

Study Arms (1)

Temozolomide and Vinorelbine

EXPERIMENTAL

Patients will be treated with vinorelbine on days 1 and 8 of each cycle; temozolomide will be administered on days 1 to 7 and 15 to 21 of each cycle. The dose level of temozolomide will be given at a dose of 150 mg/m2/day. A cycle will be defined as 28 days of treatment.

Drug: temozolomide; Drug: vinorelbine tartrate

Interventions

temozolomide DRUG

Temozolomide and Vinorelbine

vinorelbine tartrate DRUG

Temozolomide and Vinorelbine

Eligibility Criteria

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

You may qualify if:

• Age \> or = 18 years.
• Karnofsky performance score \> or = 60.
• Histopathologic confirmation of the diagnosis of a solid tumor malignancy. The brain metastasis diagnosis per se does not have to be pathologically confirmed if the clinical and neuro radiographic picture is typical.
• MRI (or CT if the patient cannot undergo MRI) evidence of evaluable disease in the brain.
• Absolute neutrophil count \> or = 1,500/mm³. Platelet count \> or = 100,000/mm³.
• Hemoglobin \> or = 10 g/dl.
• BUN and serum creatinine both \< 1.5 times upper limit of normal.
• Total and direct bilirubin both \< 1.5 times upper limit of normal.
• SGOT and SGPT both \< or = 3 times upper limit of normal.
• Alkaline phosphatase \< or = 2 times upper limit of normal.
• At least two weeks must have elapsed from brain biopsy, craniotomy, or other surgery.
• Life expectancy \> or = 8 weeks.
• Patient or their legal guardian or legal next-of-kin must provide written informed consent prior to patient's registration on study.
• At least four weeks must have elapsed from previous external beam radiation therapy, or eight weeks from stereotactic radiosurgery.
• Patients treated with radiosurgery should have evidence of progression at a distant site in the brain, or confirmation of tumor progression by biopsy or PET scan.

You may not qualify if:

• Previous treatment with temozolomide, dacarbazine or vinorelbine.
• Patients who have not recovered from all acute toxicities of prior therapies.
• Patients with evidence of leptomeningeal metastases or primary dural metastases.
• Patients who are poor medical risks because of nonmalignant systemic disease, as well as those with acute infection requiring treatment with intravenous antibiotics.
• Patients whose psychiatric condition would, in the judgment of the principal investigator, make it unlikely that they could adhere to the requirements of the protocol.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Northwestern Memorial Hospital: collaborator

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• Iwamoto FM, Omuro AM, Raizer JJ, Nolan CP, Hormigo A, Lassman AB, Gavrilovic IT, Abrey LE. A phase II trial of vinorelbine and intensive temozolomide for patients with recurrent or progressive brain metastases. J Neurooncol. 2008 Mar;87(1):85-90. doi: 10.1007/s11060-007-9491-3. Epub 2007 Nov 7.

  PMID: 17987262 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Temozolomide; Vinorelbine

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; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Dr. Lisa Deangelis
• Organization: Memorial Sloan Kettering Cancer Center

deangell@mskcc.org

212-639-7997

Study Officials

• Lauren E. Abrey, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: November 9, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 18, 2016
• Results First Posted: January 18, 2016

Record last verified: 2015-12

Locations

US (2)