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Anti-cancer agent

DepoCyt + Temozolomide for Metastases

Phase 1
Waitlist Available
Led By Morris D. Groves, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

Objectives: - To determine the safety, tolerability and maximum tolerated dose (MTD) of oral temozolomide using a 7 days on and 7 days off regimen combined with intrathecal liposomal cytarabine (DepoCyt) in patients with neoplastic meningitis from solid tumors and systemic lymphoma.

Eligible Conditions
  • Metastases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose (MTD) for the combination of Temozolomide and DepoCyt

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DepoCyt + TemozolomideExperimental Treatment2 Interventions
DepoCyt Starting 50 mg Intrathecal Day 1 every 14 days for 12 weeks (6 treatments), then every 28 days for 40 weeks (10 treatments). Temozolomide 100 mg/m\^2 by mouth daily for 7 days every 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
FDA approved

Find a Location

Who is running the clinical trial?

Schering-PloughIndustry Sponsor
162 Previous Clinical Trials
41,509 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,068 Previous Clinical Trials
1,802,668 Total Patients Enrolled
2 Trials studying Metastases
321 Patients Enrolled for Metastases
Enzon Pharmaceuticals, Inc.Industry Sponsor
24 Previous Clinical Trials
1,607 Total Patients Enrolled
~1 spots leftby Nov 2025
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