Clinical Trials Logo
  1. Home
  2. Malignant Glioma
  3. NCT00283556
  4. Details
NCT00283556 Clinical Trial

High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma

Malignant Glioma Clinical Trial

Official title:
Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00283556
Other study ID # 1068114
Secondary ID 44OE-ONC-0020-3
Status Completed
Phase Phase 1/Phase 2
First received January 26, 2006
Last updated January 18, 2010
Start date August 2001
Est. completion date December 2008

Study information
Verified date January 2010
Source Kentuckiana Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.

Description:

This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- recurrent, unresectable primary CNS neoplasm per MRI

- ECOG status of 2 or less

- no prior therapy with camptothecans

- on an enzyme-inducing antiepileptic

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Irinotecan (Camptosar, CPT-11)
Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes Q 3 weeks x 15 patients; Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients; Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.

Locations
Country Name City State
United States Kentuckiana Cancer Institute Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Kentuckiana Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors. 2008
See also
  Status Clinical Trial Phase
Terminated NCT02764151 - First in Patient Study for PF-06840003 in Malignant Gliomas Phase 1
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Completed NCT00953121 - Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG) Phase 2
Completed NCT00766467 - A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Phase 2
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT05045027 - Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma Early Phase 1
Completed NCT02507583 - Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma Phase 1
Completed NCT04109209 - Psychological Intervention For Brain Tumor Caregivers N/A
Recruiting NCT04937413 - The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation Early Phase 1
Completed NCT03615404 - Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma Phase 1
Active, not recruiting NCT04175301 - Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas. Phase 2
Terminated NCT02659800 - Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas Phase 1
Active, not recruiting NCT02323880 - Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas Phase 1
Completed NCT00782756 - Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma Phase 2
Terminated NCT02855086 - Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery Phase 1/Phase 2
Completed NCT00634231 - A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors Phase 1
Completed NCT02861222 - Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma Phase 1
Completed NCT01792505 - Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma Phase 1
Completed NCT00190723 - A Study of LY317615 in Patients With Brain Tumors Phase 2
Recruiting NCT04323046 - Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults Phase 1