Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers

NCT00141765 | Completed Phase 2 Results DMC

• 2 other identifiers: UMCC 9626IRB 1996-195
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer.

Conditions

Wilms Tumor; Fibrosarcoma; Carcinoma, Round Cell; Nasopharyngeal Cancer; Brain Tumor, Recurrent

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Progression Free Survival at 1 Year

  The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.

  1 year post transplant

Study Arms (1)

Myeloablative Chemotherapy with Stem Cell Rescue

EXPERIMENTAL

Myeloablative Chemotherapy, followed by stem cell rescue

Procedure: Myeloablative Chemotherapy; Procedure: Stem Cell Rescue

Interventions

Myeloablative Chemotherapy PROCEDURE

High dose chemotherapy (carboplatin and thiotepa) transplant rescue

Myeloablative Chemotherapy with Stem Cell Rescue

Stem Cell Rescue PROCEDURE

autologous stem cell transplantation

Myeloablative Chemotherapy with Stem Cell Rescue

Eligibility Criteria

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

You may qualify if:

• Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which:
• is metastatic and has \< 25% cure rate with conventional treatment; or
• progressed after prior chemotherapy and has \< 25% salvage rate with non-myeloablative therapies.
• Disease status: Within 3 weeks of initiation of this protocol, patients must:
• be in a complete or good partial remission (section 7.4); or
• have a "chemosensitive" tumor, which is defined as a \> 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy, without evidence of progressive disease by any other parameter.
• Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of:
• courses of high-dose cyclophosphamide, totaling \> 4200 mg/m2; or
• courses of high-dose ifosfamide totaling \> 12 gm/m2.
• course of "a)" above, plus 1 course of 'b)" above.
• Equivalent high dose alkylating agents as described in 3.3 a, b, and c.
• Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6).
• Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):
• Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or,
• Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Wilms Tumor; Fibrosarcoma; Carcinoma; Nasopharyngeal Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. John E. Levine, MD
• Organization: University of Michigan Cancer Center

jelevine@umich.edu

734-936-8456

Study Officials

• John E. Levine, MS MD

  The Univeristy of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: 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: Professor of Pediatrics and of Internal Medicine

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: January 1, 1997
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2010
• Last Updated: June 20, 2014
• Results First Posted: June 20, 2014

Record last verified: 2014-05

Locations

US (1)