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Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)

Study Purpose

The purpose of the study is to determine the effectiveness of an investigational drug called lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of Glioblastoma Multiforme (GBM).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Main

Inclusion Criteria:

1. 18 and 70 years of age in India, 18 years and above in US. 2. Histologically proven GBM who.
  • - May or may not have undergone surgery.
  • - Is scheduled to receive treatment with temozolomide and radiation.
3. Karnofsky score ≥ 70%. Main

Exclusion Criteria:

1. Diagnosis of recurrent brain tumor. 2. Received temozolomide previously. 3. Absolute neutrophil count ≤ 1.5 X 109/L. 4. Screening platelet count < 100 K/uL. 5. Screening bilirubin > 1.6 mg/dL. 6. Screening creatinine > 2.25 mg/dL in men and 1.8 mg/dL in women. 7. Screening ALT or AST > 2.5 times the upper limit of the laboratory reference range. 8. Unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study. 9. Enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product. 10. Receiving, or plans to receive, an anti-cancer therapy other than temozolomide during the study. 11. Received prior chemotherapy or radiation therapy within four weeks of enrollment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01587144
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Spectrum Pharmaceuticals, Inc
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries India, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Additional Details

This is an international, multicenter, randomized, double blind placebo controlled phase II study to evaluate the safety and efficacy of lucanthone administered as an adjunct to patients receiving primary treatment of GBM with temozolomide and radiation. Eligible patients will be randomized to lucanthone or placebo arm in ratio of 1:1. The treatment period will be in two phases ; an initial six weeks of concomitant therapy with temozolomide and radiation, followed by a maintenance phase of six cycles of temozolomide given on Days 1 to 5 of a 28- day cycle (+/- 3 days). Lucanthone / placebo will be given as an add on in both concomitant and maintenance phases.

Arms & Interventions

Arms

Placebo Comparator: Placebo

Participants will receive a matching placebo as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).

Active Comparator: Lucanthone

Participants will receive Lucanthone as an adjunct in initial six weeks of concomitant therapy with TMZ and radiation, followed by a maintenance phase of six cycles of TMZ given on Days 1 to 5 of a 28-day cycle (+/- 3 days).

Interventions

Drug: - Lucanthone

Lucanthone will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.

Drug: - Temozolomide (TMZ)

TMZ is administered at 75mg/m2 daily for 42 days during the concomitant phase. TMZ is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment. Cycles 2-6: At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the common terminology criteria (CTC) nonhematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.

Radiation: - Radiation

60 Gy administered in 30 fractions for 42 days in the concomitant phase.

Drug: - Placebo

Placebo will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSD Moores Cancer Center, La Jolla, California

Status

Address

UCSD Moores Cancer Center

La Jolla, California, 92093

UCI Medical Center, Orange, California

Status

Address

UCI Medical Center

Orange, California, 92868

Dent Neurologic Institute, Amherst, New York

Status

Address

Dent Neurologic Institute

Amherst, New York, 14226

Cleveland, Ohio

Status

Address

Fairview Hospital Moll Cancer Center/Cleveland Clinic

Cleveland, Ohio, 44111

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Mayfield, Ohio

Status

Address

Hillcrest Hospital Hirsh Cancer Center/Cleveland Clinic

Mayfield, Ohio, 44124

International Sites

Gujarat Cancer Research Institute, Ahmedabad, Gujarat, India

Status

Address

Gujarat Cancer Research Institute

Ahmedabad, Gujarat, 380016

Jaslok Hospital & Research Centre, Mumbai, Maharashtra, India

Status

Address

Jaslok Hospital & Research Centre

Mumbai, Maharashtra, 400062

Jaipur, Rajasthan, India

Status

Address

Bhagwan Mahaveer Cancer Hospital & Reseach Centre

Jaipur, Rajasthan, 302017

Chittaranjan National Cancer Institute, Kolkata, West Bengal, India

Status

Address

Chittaranjan National Cancer Institute

Kolkata, West Bengal, 700026

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