Metronomic Temozolamide in Patients With Recurrent Glioblastoma

NCT01308632 | Unknown Phase 2

• 1 other identifier: GENOM-007
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Indication: Subjects with glioblastoma at first relapse after surgery, radiotherapy and first-line temozolomide (TMZ). Objectives:

• To assess the correlation between immunohistochemical expression of PTEN and MGMT proteins, and clinical outcomes.

Conditions

Glioblastoma

Keywords

glioblastoma; temozolamide; radiotherapy; TMZ; irinotecan

Outcome Measures

Primary Outcomes (2)

• Efficacy of the treatment (Phase I)

  To determine the maximum tolerated dose (MTD) of CPT-11 administered on days 8 and 22 in combination with a fixed, continuous and metronomic regimen of TMZ, given in 28-days cycles to use the Recommended Dose in phase II

  every patient should receive at least one cycle ( 28 days)

• Progression-free survival (Phase II)

  The time the patient is not in progression, since the beginning of the treatment

  Since the initial of the treatment until the patient progression

Secondary Outcomes (3)

• Assess the toxicity of the treatment

  the patients will be followed until disease progression

• Progression-free survival at 6 months

  6 months since the pacient is included in the trial

• overall survival

  the patients will be followed until death

Study Arms (1)

Temozolamide, irinotecan

EXPERIMENTAL

Phase I trial: TMZ will be administered in a fixed schedule as follows: TMZ 50 mg/m2/day divided in three daily doses (approx. 17 mg/m2/8 hours) on days 1-7, 9-21, and 23-28. 100 mg/m2 in a morning single dose on days 8 and 22 CPT-11 starting dose: 100 mg/m2 on days 8 and 22, administered 3 to 6 hours after TMZ. (Level 1) One cycle = 28 days CPT-11 will be escalated in successive cohorts of 3 patients as follows: 115, 130, 145, 160 mg/m2 .

Drug: Temozolamide, irinotecan

Interventions

Temozolamide, irinotecan DRUG

Phase I trial: TMZ will be administered in a fixed schedule as follows: TMZ 50 mg/m2/day divided in three daily doses (approx. 17 mg/m2/8 hours) on days 1-7, 9-21, and 23-28. 100 mg/m2 in a morning single dose on days 8 and 22 CPT-11 starting dose: 100 mg/m2 on days 8 and 22, administered 3 to 6 hours after TMZ. (Level 1) One cycle = 28 days CPT-11 will be escalated in successive cohorts of 3 patients as follows: 115, 130, 145, 160 mg/m2 .

Also known as: CPT-11, Campto, Irinotecan, Temozolamide

Temozolamide, irinotecan

Eligibility Criteria

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

You may qualify if:

• Patients \> 18 years old
• Histological confirmed GB at first relapse, assessed by MRI scan, after surgical resection or biopsy, radiotherapy, and first-line chemotherapy with TMZ. A TMZ treatment duration of at least 3 months is required. Previous chemotherapy with CPT-11 is not allowed.
• Karnofsky performance status ≥ 70.
• ANC ≥ 1500/ μl, platelet count ≥ 100000/ μl, haemoglobin \> 10 g/dl, serum creatinine and total bilirubin \< 1.5 times the upper limit of laboratory normal, transaminases \< 3.0 times the upper limit of laboratory normal.
• Stable or descending corticosteroid dose ≥ 72 hours before baseline MRI and study treatment.
• Life expectancy greater than 3 months
• Written informed consent.

You may not qualify if:

• Pregnancy or breastfeeding.
• Neurological impairment that precludes comprehension or treatment administration
• Vomiting or other condition that interfere with oral administration of TMZ
• Previous or concurrent malignancy, excluding basal cell carcinomas or in situ cervical cancer.
• Concurrent disease that could interfere with treatment
• Concurrent treatment with enzyme-inducing drugs. Patients under enzyme-inducing anticonvulsants should discontinue treatment at least one week before study treatment and begin a new anti-epileptic treatment with non enzyme-inducing drugs if indicated.

Sponsors & Collaborators

• Grupo Español de Investigación en Neurooncología: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Reynés Gaspar, Dr

  Hospital Universitario La Fe de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: March 4, 2011
• Study Start: November 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 4, 2011

Record last verified: 2011-03