Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

NCT00360828 | Terminated Phase 2 Results DMC

• 1 other identifier: MCC-14633
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.

Conditions

Astrocytoma; Glioma; Oligodendroglioma

Keywords

Recurrent Anaplastic Astrocytoma; Mixed Malignant Glioma; Oligodendroglioma; Irinotecan; Brain tumor; Nitrosoureas; Brain and nervous system

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Objective Response After 3 Cycles of Treatment

  The intent was to have 63 evaluable participants to determine the Objective Response Rate utilizing Criteria for Response, Progression and Relapse according to the McDonald Criteria. A measurement is made of the maximal enhancing tumor diameter on a single axial gadolinium-enhanced T1-weighted section, and then the largest perpendicular diameter is measured on the same image. The product of the 2 diameters is calculated, and the measurements are repeated with each scan. Measurements from multiple lesions are summed.

  3 cycles (21 day cycles)

Secondary Outcomes (4)

• Overall Survival at 6 Months

  6 months post treatment end

• Progression Free Survival

  1 year post treatment end

• Frequency and Severity of Toxicity

  3 months

• Overall Survival at 12 Months

  12 months post treatment end

Study Arms (1)

Irinotecan Treatment

EXPERIMENTAL

Participants were given irinotecan at a fixed dose: \[350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan\] once every 21 days. Depending on how many side effects were experienced with the first cycle \[first 21 days\], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.

Drug: Irinotecan Hydrochloride (HCI) Treatment; Drug: Continued Irinotecan Hydrochloride (HCI) Treatment

Interventions

Irinotecan Hydrochloride (HCI) Treatment DRUG

Irinotecan injections. Irinotecan hydrochloride \[CPT-11; CAMPTOSAR\] is an antineoplastic agent of the topoisomerase I inhibitor class. The drug is supplied in amber vials and appears as a pale yellow transparent aqueous solution. Two vial sizes are available: 2 mL vials containing 40 mg of drug and 5 mL vials containing 100 mg of drug. A treatment cycle was 21 days. Patients were treated for a minimum of 3 cycles (doses) of CPT-11 or until their disease progressed.

Also known as: CPT-11, CAMPTOSAR, Irinotecan HCL

Irinotecan Treatment

Continued Irinotecan Hydrochloride (HCI) Treatment DRUG

For patients responding to treatment, therapy could have continued beyond 18 cycles.

Also known as: CPT-11, CAMPTOSAR, Irinotecan HCL

Irinotecan Treatment

Eligibility Criteria

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

You may qualify if:

• Patients must have histological or neuroradiographic documented recurrent glioma defined as an anaplastic astrocytoma, mixed malignant glioma or oligodendroglioma. All patients must have had prior pathologic confirmation of primary tumor histology.
• Patients must be \> than or equal to 18 years old.
• Patients must have a Karnofsky performance score (KPS) of \> or equal to 50
• Measurable disease per MacDonald criteria is required
• Patients must have a predicted life expectancy of at least 12 weeks
• Required initial laboratory data:
• Absolute Neutrophil Count (ANC) \> 1,500
• Platelets \> 100,000
• Serum Creatinine \< 2.0
• Serum Bilirubin \< 2.0
• Aspartamine transaminase/ Alanine transaminase (AST/ALT) \< 3x normal
• Pregnancy test for females with child-bearing potential negative
• Patients must sign and date an IRB approved informed consent form stating he or she is aware of the neoplastic nature of the disease. Patient must willingly provide written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. (Human protection committee approval of this protocol and consent form is required).
• Patients must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests and accessible for follow-up.
• Patients must have been previously treated with both surgery and radiotherapy.

You may not qualify if:

• Patients have evidence of leptomeningeal spread of disease.
• Patients having been treated with 2 or more salvage regimens.
• Pregnant or breast-feeding women. With the exception of post-menopausal or infertile women, a negative blood test for pregnancy is mandatory before entry on study. Fertile persons refusing to use adequate contraceptives may not participate.
• Patients with a history of irritable bowel disease, irritable bowel syndrome, chronic diarrhea or presence of a bowel obstruction.
• Patients with a second active malignancy or diagnosis of other cancer within 3 years of enrollment, except for surgically cured basal cell carcinoma, or in situ carcinoma of the cervix.
• Mentally incapacitated patients or psychiatric illness that would prevent the patient from giving informed consent.
• Patients with poorly controlled diabetes, hepatitis infection, uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, and myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.
• Known to be human immunodeficiency virus (HIV) positive or to have an acquired immunodeficiency syndrome (AIDS) related illness.
• Patients with an active infection that is not adequately controlled with antibiotics.
• Patients with other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
• Patients with a known sensitivity to any of the products to be administered during treatment.
• Patients currently enrolled in another clinical trial or patients who have participated in a trial of an investigational device or drug within the last 30 days.
• Patients previously treated with CPT-11.
• Concurrent stereotactic radiotherapy.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Astrocytoma; Glioma; Oligodendroglioma; Brain Neoplasms; Neurologic Manifestations

Interventions

Irinotecan; Therapeutics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Limitations and Caveats

Low accrual prevented us from completing the planned analysis. The initial Principal Investigator (PI) left Moffitt and there were only 10 participants.

Results Point of Contact

• Title: Edward Pan, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

edward.pan@moffitt.org

813-745-3871

Study Officials

• Edward Pan, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 7, 2006
• Study Start: February 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 23, 2017
• Results First Posted: December 9, 2011

Record last verified: 2011-11

Locations

US (1)