Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With M… (NCT00006234) | Clinical Trial Compass
CompletedPhase 1/2
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
United StatesStarted 2001-11
Plain-language 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.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…