Clinical Trials Logo

Clinical Trial Summary

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b in treating young patients with plexiform neurofibroma.


Clinical Trial Description

OBJECTIVES:

Primary

- Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with unresectable plexiform neurofibroma. (Dose escalation portion of study closed to accrual as of 2/2005.)

- Determine the toxicity profile of this drug in these patients.

Secondary

- Obtain, preliminary, information about the efficacy of this drug in these patients.

- Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in patients treated with this drug.

- Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.

OUTLINE: This is a dose-escalation, multicenter study. (Dose-escalation portion of the study closed to accrual as of 2/2005.)

Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 2 years in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PEG-interferon alfa-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.

After completion of study treatment, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00253474
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 1
Start date September 2005
Completion date January 2011

See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT01164163 - INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease Phase 1
Terminated NCT00949117 - Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer Phase 2
Completed NCT00985868 - AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors Phase 1
Completed NCT00281944 - Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors Phase 1
Recruiting NCT00084695 - Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases Phase 2
Completed NCT00053963 - FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia Phase 1
Completed NCT00003070 - Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer Phase 3
Completed NCT00004212 - DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00003754 - Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers Phase 2
Completed NCT00004005 - Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin Phase 2
Completed NCT00016861 - Irinotecan in Treating Children With Refractory or Progressive Solid Tumors Phase 1
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Recruiting NCT00898794 - Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer N/A
Terminated NCT00429702 - Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy Phase 2
Completed NCT00459238 - Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants N/A
Completed NCT00387920 - Sunitinib in Treating Young Patients With Refractory Solid Tumors Phase 1
Completed NCT00138216 - Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors Phase 1
Completed NCT00070473 - Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors Phase 1
Terminated NCT00176540 - Dextromethorphan in Treating Patients With Fatigue Caused by Cancer N/A