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.
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
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.
- Conditions
- Metastatic Cancer, Sarcoma
- 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.
peripheral blood stem cell transplantationProcedure or surgery
holmium Ho 166 DOTMPRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2001
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Douglas Hawkins, MD, Study chair, Fred Hutchinson Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00006234
- Acronym / sponsor ID
- 1474.00
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2001
- Study completion
- Mar 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral blood stem cell transplantation | Procedure or surgery | – |
| holmium Ho 166 DOTMP | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Hawkins, MD study chair
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
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.