Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone

NCT00006234 | Completed Phase 1

• 5 other identifiers: 1474.00FHCRC-1474.00CHMC-S-6007NCI-G00-1842CDR0000068159
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radioactive drugs, such as holmium Ho 166 DOTMP, may carry radiation directly to cancer cells and not harm normal cells. Peripheral stem cell transplantation may be able to replace stem cells that were destroyed by the radioactive drug. PURPOSE: This Phase I/II trial is studying the effectiveness of holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients who have metastatic Ewing's sarcoma or rhabdomyosarcoma that has spread to the bone.

Conditions

Metastatic Cancer; Sarcoma

Keywords

recurrent childhood rhabdomyosarcoma; recurrent adult soft tissue sarcoma; adult rhabdomyosarcoma; bone metastases; previously treated childhood rhabdomyosarcoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; stage IV adult soft tissue sarcoma

Interventions

peripheral blood stem cell transplantation PROCEDURE

holmium Ho 166 DOTMP RADIATION

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed Ewing's sarcoma family of tumors or rhabdomyosarcoma with bone metastases * Refractory to conventional therapy OR * Responsive to conventional therapy with osseous metastases at diagnosis that are extensive enough to preclude concurrent radiotherapy to all sites * Soft tissue, pulmonary, and/or bone marrow metastases in addition to cortical bone allowed * Extraosseous sites of disease allowed if amenable to surgical resection or external beam radiotherapy * No patients under 10 years old with embryonal rhabdomyosarcoma * Adequate peripheral blood stem cells stored * At least 2,500,000 CD34+ cells/kg * No impending bone fracture or spinal cord compression PATIENT CHARACTERISTICS: Age: * 12 and over Performance status: * 0-2 Life expectancy: * At least 2 months Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 (transfusion independent) * Hemoglobin at least 10.0 g/dL (RBC transfusion allowed) Hepatic: * Bilirubin no greater than 1.5 times normal * SGOT no greater than 2.5 times normal Renal: * Radioisotope glomerular filtration rate, iothalamate clearance, or creatinine clearance at least 60 mL/min Other: * No uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior immunotherapy * At least 3 months since prior bone marrow or peripheral blood stem cell transplantation (6 months for total body irradiation conditioning) and recovered * At least 1 week since prior cytokines * No immunomodulators during and for at least 4 weeks after study * No concurrent cytokines Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * No more than 3 prior systemic chemotherapy regimens * No systemic chemotherapy during and for at least 4 weeks after study Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * See Biologic therapy * Recovered from prior radiotherapy * No prior maximum tolerable radiotherapy (greater than 30 Gy) to the spinal cord * No prior therapeutic doses of bone-seeking radiopharmaceutical (e.g., samarium Sa 153 lexidronam pentasodium EDTMP) * No radiotherapy during and for at least 4 weeks after study * Local radiotherapy to any tumor site allowed provided at least 1 evaluable lesion is untreated Surgery: * See Disease Characteristics * No surgical resection of all bone metastases evaluable by PET during and for 1 month after study Other: * At least 4 weeks since prior bisphosphonates

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Sarcoma; Rhabdomyosarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Peripheral Blood Stem Cell Transplantation; holmium-1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetrakis(methylenephosphonic acid)

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Myosarcoma; Neoplasms, Muscle Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Douglas Hawkins, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: January 27, 2003
• Study Start: November 1, 2001
• Study Completion: March 1, 2006
• Last Updated: December 1, 2011

Record last verified: 2011-11

Locations

US (1)