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Completed

NCT Number: NCT00098865

Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma

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.

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Key information

Conditions

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

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

OBJECTIVES:

Primary

  • Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas.

Secondary

  • Determine preliminarily evidence of biologic activity of this regimen in these patients.
  • Determine the toxic effects of this regimen in these patients.

STATISTICAL DESIGN: The primary data analysis will estimate the percentage of patients who can complete 6 months of therapy in the mixed population. With a target accrual of 20 patients the 90% confidence for the true feasibility rate will be no wider than 40%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Temodar

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.

Other names: Thalamid

Primary outcomes

  1. Therapy Completion Rate

    Time frame: 6 months

    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.

Secondary outcomes

  1. Overall Response

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

    Overall response is the best response during 6 months of therapy measured by radiographic response.

    Complete Response (CR): Disappearance of all detectable tumors by imaging, if initially positive, as well as 2 consecutively negative CSF cytologic examinations (if the initial cytology was positive).

    Partial Response (PR): > 50% reduction in the sum of the products of the maximum perpendicular diameter of all measurable lesions; or 2 consecutively negative CSF cytologies and a < 50% reduction in tumor size.

    Stable Disease (SD): < 50% reduction in the sum of the products of the maximum perpendicular diameters of all measurable lesions, and persistently negative or positive CSF cytology Progressive Disease (PD): > 25% increase in the size of any measurable lesion, the appearance of a new radiographically demonstrable lesion, or the conversion of negative CSF cytology to positive, as confirmed by at least one repeat CSF cytology

  2. Overall Survival

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

    Time from registration to death. Patients alive at last follow-up were censored.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Boston Children's Hospital
  • Celgene Corporation
  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2004
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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