ATN-161 and Carboplatin in Treating Patients With Recurrent Malignant Glioma

NCT00352313 | Completed Phase 1

• 5 other identifiers: 06017006-C-0170NCI-P6790ATN-161-002CDR0000487605
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ATN-161 together with carboplatin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of ATN-161 when given together with carboplatin and to see how well they work in treating patients with recurrent malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic oligodendroglioma; adult gliosarcoma; adult mixed glioma; adult anaplastic astrocytoma; recurrent adult brain tumor; adult glioblastoma; adult giant cell glioblastoma

Outcome Measures

Primary Outcomes (5)

• Safety

• Maximum tolerated dose (phase I)

• Progression-free survival at 6 months

• Response rate (phase I)

• Overall survival

Secondary Outcomes (2)

• Efficacy

• Response rate (phase II)

Study Arms (2)

Phase I

EXPERIMENTAL

Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: ATN-161; Drug: carboplatin

Phase II

EXPERIMENTAL

Patients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Drug: ATN-161; Drug: carboplatin

Interventions

ATN-161 DRUG

Given IV

Phase I; Phase II

carboplatin DRUG

Given IV

Phase I; Phase II

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed intracranial malignant glioma * Original low-grade glioma histology allowed provided there is subsequent histologic confirmation of malignant glioma * Any of the following diagnoses: * Glioblastoma multiforme * Gliosarcoma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Recurrent disease * Must have failed prior radiotherapy * Must have confirmation of true progressive disease (rather than radiation necrosis) based upon either positron emission tomography or thallium scanning, MR spectroscopy, or surgical documentation of disease if radiographic recurrence is within the high-dose radiation field (for patients who underwent prior interstitial brachytherapy or stereotactic radiosurgery) * Prior recent resection of recurrent or progressive tumors allowed if all of the following criteria are met: * Recovered from prior surgery * Evaluable disease after resection * Unequivocal evidence of tumor progression by MRI * Steroid dose must be stable for ≥ 5 days prior to MRI PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy \> 8 weeks * WBC ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL (transfusion allowed) * AST \< 2.5 times upper limit of normal (ULN) * Bilirubin \< 2.5 times ULN * Creatinine \< 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after completion of study treatment * No significant medical illness that would preclude study treatment * No history of other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless disease is in complete remission and off all therapy for ≥ 1 year * No active infection or serious intercurrent medical illness * No disease that will obscure toxicity or dangerously alter drug metabolism * Able to undergo MRI scan and receive contrast agents for perfusion scanning PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * At least 28 days since prior cytotoxic therapy * At least 14 days since prior vincristine * At least 42 days since prior nitrosoureas * At least 21 days since prior procarbazine * At least 7 days since prior interferon, tamoxifen, thalidomide, isotretinoin, or other noncytotoxic agents (radiosensitizer does not count) * At least 14 days since prior noncytotoxic investigational agents * At least 42 days since prior radiotherapy * No prior cisplatin, carboplatin, oxaliplatin, or platinum-containing analogue * No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) * No other concurrent anticancer therapy (including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy) * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Oligodendroglioma; Gliosarcoma; Glioma; Astrocytoma; Brain Neoplasms; Glioblastoma

Interventions

acetyl-prolyl-histidyl-seryl-cysteinyl-asparaginamide; Carboplatin

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Howard A. Fine, MD

  NCI - Neuro-Oncology Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2008
• Last Updated: May 2, 2012

Record last verified: 2012-05

Locations

US (1)