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

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ClinicalTrials.gov Identifier: NCT00006234

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : December 1, 2011

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Fred Hutchinson Cancer Center

Tracking Information

First Submitted Date ^ICMJE

September 11, 2000

First Posted Date ^ICMJE

January 27, 2003

Last Update Posted Date

December 1, 2011

Study Start Date ^ICMJE

November 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1
Phase 2

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Cancer
Sarcoma

Intervention ^ICMJE

Procedure: peripheral blood stem cell transplantation
Radiation: holmium Ho 166 DOTMP

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

March 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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:

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

12 Years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00006234

Other Study ID Numbers ^ICMJE

1474.00
FHCRC-1474.00
CHMC-S-6007
NCI-G00-1842
CDR0000068159 ( Registry Identifier: PDQ )

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Not Provided

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Fred Hutchinson Cancer Center

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Douglas Hawkins, MD

Fred Hutchinson Cancer Center

PRS Account

Fred Hutchinson Cancer Center

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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