Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

NCT00109798 | Withdrawn

• 2 other identifiers: BCM IRB#H-16155CDR0000427313
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan works in treating patients with primary CNS lymphoma.

Conditions

Central Nervous System Tumors; Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma; primary central nervous system Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Rate of complete radiologic response (CR)

  July 2006

Secondary Outcomes (4)

• Median overall survival

  July 2006

• Failure-free survival

  July 2006

• Toxicity

  July 2006

• Overall response rate (CR and partial response)

  July 2006

Study Arms (1)

Temozolomide, Topotecan

EXPERIMENTAL

Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule

Drug: temozolomide; Drug: topotecan hydrochloride

Interventions

temozolomide DRUG

Patient will take drug on day 1-5 of 28 day schedule

Also known as: Temodar

Temozolomide, Topotecan

topotecan hydrochloride DRUG

Patient will have IV on days 2-6 on a 28-day schedule

Also known as: Topotecan

Temozolomide, Topotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DISEASE CHARACTERISTICS:
• Histologically confirmed primary CNS lymphoma at initial diagnosis
• Measurable tumor by radiography
• Failed\* OR is not a candidate for first-line high-dose systemic methotrexate-based chemotherapy with or without radiotherapy NOTE: \*Failure is defined as relapse, progression, or failure to achieve a complete response
• PATIENT CHARACTERISTICS:
• Age
• and over
• Performance status
• Karnofsky 50-100%
• Life expectancy
• Not specified
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Baylor College of Medicine: collaborator

MeSH Terms

Conditions

Central Nervous System Neoplasms; Lymphoma

Interventions

Temozolomide; Topotecan

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pamela Z. New, MD

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: March 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share