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A Phase I/II Study of 166Ho-DOTMP With Peripheral Blood Progenitor Cell Support for Refractory or Recurrent Ewing's Sarcoma Family of Tumors With Bone Disease


Phase 1/Phase 2
12 Years
N/A
Not Enrolling
Both
Metastatic Cancer, Sarcoma

Thank you

Trial Information

A Phase I/II Study of 166Ho-DOTMP With Peripheral Blood Progenitor Cell Support for Refractory or Recurrent Ewing's Sarcoma Family of Tumors With Bone Disease


OBJECTIVES:

- Determine the dosimetry of holmium Ho 166 DOTMP in patients with metastatic Ewing's
sarcoma family of tumors or rhabdomyosarcoma with bone metastases.

- Provide treatment with holmium Ho 166 DOTMP for these patients.

- Determine the toxicity and pharmacokinetics of this drug in these patients.

- Determine the change in tumor cell content in peripheral blood and bone marrow after
treatment with this drug in these patients.

OUTLINE: Patients receive a trace dose of holmium Ho 166 DOTMP IV over 10 minutes on day -7
and an assigned dose over 10 minutes on day 0. Autologous peripheral blood stem cells are
infused on days 7-10.

Patients are followed at least weekly for 4 weeks and then monthly for 1 year or until
disease progression.

PROJECTED ACCRUAL: A total of 4 patients will be accrued for this study.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Douglas Hawkins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1474.00

NCT ID:

NCT00006234

Start Date:

November 2001

Completion Date:

March 2006

Related Keywords:

  • Metastatic Cancer
  • Sarcoma
  • 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
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Rhabdomyosarcoma
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109