Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma

NCT00098865 | Completed Phase 2 Results DMC

• 3 other identifiers: 01-279 DFCIP30CA006516CDR0000396780
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may kill more tumor cells. PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma.

Conditions

Central Nervous System Tumor, Pediatric; Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• Therapy Completion Rate

  Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.

  6 months

Secondary Outcomes (2)

• Overall Response

  Assessed every 8 weeks while on treatment and every 3 months for one year off-study

• Overall Survival

  Assessed after treatment discontinued every 3 months up to 2 years.

Study Arms (1)

Thalidomide and Temozolomide

EXPERIMENTAL

Thalidomide: Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated. Temozolomide: Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation. Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression

Drug: temozolomide; Drug: thalidomide

Interventions

temozolomide DRUG

The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.

Also known as: Temodar

Thalidomide and Temozolomide

thalidomide DRUG

Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.

Also known as: Thalamid

Thalidomide and Temozolomide

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed\* diagnosis of 1 of the following: * Poor prognosis brain tumor * Relapsed or progressive disease * No curative therapy exists * Neuroblastoma * Recurrent disease NOTE: \*Histologic confirmation not required for brain stem glioma; patients with brain stem glioma must have clinical and radiographic evidence of disease * Patients with brain stem glioma must have symptoms lasting \< 3 months comprising cranial nerve deficits (often VI or VII) and/or ataxia and/or long tract signs PATIENT CHARACTERISTICS: Age * 21 and under Performance status * Karnofsky 50-100% OR * Lansky 50-100% Life expectancy * More than 2 months Hematopoietic * Hemoglobin ≥ 9.0 g/dL * Platelet count \> 75,000/mm\^3 * WBC \> 2,000/mm\^3 * Absolute neutrophil count \> 1,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * SGOT and SGPT ≤ 2 times normal (SGOT ≤ 4 times normal for patients taking Zantac) * Alkaline phosphatase ≤ 2 times normal * No active hepatic disease ≥ grade 3 Renal * Creatinine \< 1.5 mg/dL OR * Creatinine clearance ≥ 70 mL/min * No active renal disease ≥ grade 3 Cardiovascular * No active cardiac disease ≥ grade 3 Pulmonary * No active pulmonary disease ≥ grade 3 Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * Willing and able to participate in the System for Thalidomide Education and Prescription Safety (S.T.E.P.S.\^®) program * No active psychiatric disease ≥ grade 3 PRIOR CONCURRENT THERAPY: Biologic therapy * Prior biologic therapy allowed * No prior thalidomide Chemotherapy * Prior chemotherapy allowed * No prior temozolomide Endocrine therapy * Concurrent steroids allowed Radiotherapy * Prior radiotherapy allowed Surgery * Prior surgery allowed Other * Concurrent antiseizure medications allowed * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Boston Children's Hospital: collaborator
• Celgene Corporation: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neuroblastoma

Interventions

Temozolomide; Thalidomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Mark W. Kieran, MD, PhD
• Organization: DFCI

mark_kieran@dfci.harvard.edu

617-632-4907

Study Officials

• Mark W. Kieran, MD, PhD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: September 1, 2002
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 7, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (1)