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

NCT ID: NCT00141765

Last Updated: 2014-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31
• Study Completion Date: 2010-02-28

Brief Summary

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

Detailed Description

This is a phase II trial designed to provide a transplant option for patients with rare poor-prognosis cancers. The protocol is only open to patients with metastatic or relapsed cancers for whom the probability of remaining free of progressive disease for one year after being brought into remission is < 25%. Patients eligible for this study have been diagnosed with a form of cancer that leads to death more than 75% of the time when treated with standard therapy doses of chemotherapy and/ or radiation therapy. Under this treatment intensification protocol the expectation is that the one year progression-free survival for this group of patients will rise to 40%. Patients eligible for this protocol will be followed for one year post-transplant. Patients alive and free of progressive disease at the end of this period will be considered successes.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Myeloablative Chemotherapy with Stem Cell Rescue

Myeloablative Chemotherapy, followed by stem cell rescue

Group Type: EXPERIMENTAL

Myeloablative Chemotherapy

Intervention Type: PROCEDURE

High dose chemotherapy (carboplatin and thiotepa) transplant rescue

Stem Cell Rescue

Intervention Type: PROCEDURE

autologous stem cell transplantation

Interventions

Myeloablative Chemotherapy

High dose chemotherapy (carboplatin and thiotepa) transplant rescue

Intervention Type: PROCEDURE

Stem Cell Rescue

autologous stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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:

1. is metastatic and has < 25% cure rate with conventional treatment; or

2. 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:

1. be in a complete or good partial remission (section 7.4); or

2. 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:

1. 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or

2. courses of high-dose ifosfamide totaling > 12 gm/m2.

3. 1 course of "a)" above, plus 1 course of 'b)" above.

4. 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):

1. Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or,

2. Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg.

• Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

John Levine, MD

Professor of Pediatrics and of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John E. Levine, MS MD

Role: PRINCIPAL_INVESTIGATOR

The Univeristy of Michigan

Locations

The University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

IRB 1996-195

Identifier Type: -

Identifier Source: secondary_id

UMCC 9626

Identifier Type: -

Identifier Source: org_study_id