Phase II Trial of Chemotherapy With Temodar With Topotecan for CNS Metastasis of Solid Tumors

NCT01736800 | Withdrawn Phase 2 DMC

• 1 other identifier: Pro00000771
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The specific purpose of this study is to obtain data on safety and efficacy of combination chemotherapy with Temozolomide and Topotecan in patients with CNS metastases of solid tumors. Up to 35 patients will be accrued over 2-3 years and followed for up to 5 years and will receive 8 cycles of chemotherapy. The primary endpoint is the determinant median overall survival and progression-free survival of this regimen, time to progression of the brain metastases, and assessment of toxicity levels in this regimen.

Conditions

Central Nervous System (CNS) Metastases; Brain Metastases

Keywords

Temozolomide; Topotecan; Central Nervous System Metastases; Chemotherapy; Brain Metastases; Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Radiologic Response

  The primary objective of this study is to determine the overall rate of radiologic response of brain metastases to combination chemotherapy with temozolomide and topotecan in patients with CNS metastases of solid tumors

  5 years

Secondary Outcomes (1)

• Median Overall Survival

  5 years

Study Arms (1)

Temozolomide/Topotecan

EXPERIMENTAL

Temozolomide pills are to be taken on an empty stomach at night and should not be chewed. Patients receive Temozolomide on days 1-5 of a 28-day schedule. Patients will receive Topotecan intravenous treatment days 2-6 of each 28-day cycle at The Mehthodist Hospital Outpatient Infusion Center.

Drug: Topotecan; Drug: Temozolomide

Interventions

Topotecan DRUG

Patients will receive Topotecan intravenous treatment days 2-6 of each 28-day cycle at The Mehthodist Hospital Outpatient Infusion Center.

Also known as: Hycamtin

Temozolomide/Topotecan

Temozolomide DRUG

Temozolomide is taken on an empty stomach at night and should not be chewed. Patients receive Temozolomide on days 1-5 of a 28-day schedule.

Also known as: Temodar

Temozolomide/Topotecan

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for the study, patients must have evidence of progressive CNS metastases of a solid tumor (new or progressing lesions), and either:
• Have failed prior WBRT.
• Or: not be candidates for surgical intervention and not require immediate radiation therapy to relieve symptoms, and have controlled systemic disease.
• Additional requirements:
• Patients must be \> 18 years old.
• Patients must have radiographically measurable tumor on the updated scan within 2 weeks prior to starting treatment.
• Patients must have histopathologic documentation of primary tumor at the time of initial diagnosis.
• Patients must be in adequate condition at time of enrollment, as indicated by:
• Absolute neutrophil count (ANC) greater than or equal 1,500/mm3
• Hemoglobin greater than or equal 9 gm/dL
• Platelets greater than or equal 100,000/mm3
• Karnofsky Performance Status greater than or equal 50
• Creatinine clearance \>40 ml/min
• Total bilirubin less than or equal 2.0 mg/dl and SGOT, SGPT less than or equal 3 times upper limit of normal
• Patients must not be receiving concurrent anti-tumor therapy and must have recovered from toxicity of prior therapy. Minimum intervals required:

You may not qualify if:

• Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception.
• Known allergy to temozolomide or topotecan.
• Severe vomiting or other inability to administer medications orally.
• Major medical illnesses or psychiatric impairment that in the investigator's opinion will prevent administration or completion of the protocol therapy and/or will interfere with follow-up.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (2)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Methodist Neurological Institute - Department of Neurosurgery

Houston, Texas, 77030, United States

Location

Related Links

• PO 5200

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Topotecan; 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)

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

Study Officials

• Pamela Z New, M.D.

  Methodist Neurological Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 29, 2012
• Study Start: March 1, 2007
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)