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Metastatic CancerPhase 1/2NCT00006234

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

A Phase 1/2 study testing peripheral blood stem cell transplantation and holmium Ho 166 DOTMP in people with Metastatic Cancer and Sarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Metastatic Cancer, Sarcoma
What is being tested?
peripheral blood stem cell transplantation and holmium Ho 166 DOTMP
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Nov 2001to Mar 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
peripheral blood stem cell transplantation, holmium Ho 166 DOTMP
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
Medical subject headings
Neoplasm Metastasis, Sarcoma, Rhabdomyosarcoma, Neuroectodermal Tumors, Primitive, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 2001
  3. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006234
Sponsor's protocol ID
1474.00
Other IDs
FHCRC-1474.00, CHMC-S-6007, NCI-G00-1842, CDR0000068159
Status last verified
Nov 2011
First submitted
11 Sep 2000
Last updated
1 Dec 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing peripheral blood stem cell transplantation and holmium Ho 166 DOTMP in people with Metastatic Cancer and Sarcoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2011.

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