Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
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|ClinicalTrials.gov Identifier: NCT00003750|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 8, 2014
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in treating children who have refractory or recurrent neuroblastoma or other tumors.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin) Neuroblastoma Sarcoma Unspecified Childhood Solid Tumor, Protocol Specific||Biological: hu14.18-IL2 fusion protein||Phase 1|
- Determine the maximum tolerated dose of hu14.18-interleukin-2 fusion protein in children with refractory or recurrent neuroblastoma or other GD2-positive tumors.
- Determine the toxicity and pharmacokinetics of the fusion protein in these patients.
- Determine the effect of the fusion protein on systemic immune modulation in these patients.
- Quantitate the antifusion protein antibodies in patients treated with fusion protein.
- Evaluate antitumor responses resulting from this fusion protein regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive hu14.18-interleukin-2 (hu14.18-IL2) fusion protein IV over 4 hours once daily on days 1-3. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of hu14.18-IL2 fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2 months for 1 year, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IB Intergroup Trial of the HU14.18-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors|
|Study Start Date :||October 2001|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||September 2005|
Experimental: DG2 positive relapsed or refractory solid tumors
The initial hu14.18-IL2 fusion protein (FP) dose will be 2 mg/m2 given intravenously over 4 hours, daily for 3 days. Five separate dose levels are scheduled: 2 mg/m²/dose (IV over 4 hours) x 3 days, 4 mg/m²/dose (IV over 4 hours) x 3 days, 6 mg/m²/dose (IV over 4 hours) x 3 days, 8 mg/m²/dose (IV over 4 hours) x 3 days, 10 mg/m²/dose (IV over 4 hours) x 3 days.
|Biological: hu14.18-IL2 fusion protein|
- Determine the MTD and pharmacokinetics of hu14.18-IL2 fusion proteinDetermine the MTD of hu14.18-IL2 fusion protein and determine the pharmacokinetics of the fusion protein when given as I.V. injections
- Assess immunological changes associated with fusion protein therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003750
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|Study Chair:||Paul M. Sondel, MD, PhD||University of Wisconsin, Madison|