SarcomaPhase 2NCT00003667
Combination Chemotherapy and Biological Therapy in Treating Patients With High-Risk Ewing's Sarcoma
A Phase 2 study testing cyclophosphamide, dexrazoxane hydrochloride and disaccharide tripeptide glycerol dipalmitoyl in people with Sarcoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 3 to 60 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- cyclophosphamide, dexrazoxane hydrochloride and disaccharide tripeptide glycerol dipalmitoyl
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Sep 1998to Aug 2000
- Phase
- Phase 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 3 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Histologically proven high risk Ewing's family of tumors: Ewing's sarcoma of bone Extraosseous Ewing's sarcoma Peripheral neuroepithelioma Must have one of the following characteristics: Metastatic disease at diagnosis Primary tumor of the humerus, femur, or trunk Bulky (greater than 8 cm) tumor Elevated LDH prior to biopsy (at least 900 IU/mL)
PATIENT CHARACTERISTICS: Age: 3 to 60 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Granulocyte count at least 500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 3 times normal Renal: BUN less than 30 mg/dL Creatinine no greater than 1.5 times normal for age OR Creatinine clearance at least 70 mL/min Cardiovascular: Ejection fraction at least 50% OR Fractional shortening at least 29% Other: Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane With and Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without biological therapy in treating patients who have newly diagnosed high-risk Ewing's sarcoma.
Read the detailed description
OBJECTIVES: I. Compare the effects of dose intensive regimens of vincristine, doxorubicin, cyclophosphamide, and dexrazoxane with or without ImmTher (a muramyl dipeptide liposome) on the 2 year disease-free survival of patients with newly diagnosed high risk Ewing's sarcoma. II. Evaluate the feasibility and determine the toxicity of administering weekly ImmTher for 1 year to these patients. III. Determine which therapy is worthy of further evaluation.
OUTLINE: This is a randomized study. Patients are stratified according to the presence of bony metastases at diagnosis. Patients are randomized to one of two treatment arms. All patients receive dexrazoxane IV followed 30 minutes later by doxorubicin IV over 30 minutes on day 1, vincristine IV on day 1, and cyclophosphamide IV over 6 hours on days 1 and 2. Treatment is repeated every 3 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity. Patients are evaluated after course 3 and undergo surgery and/or radiation therapy. The next 3 courses of chemotherapy are administered after recovery from surgery/radiation therapy. Within 1 month after completion of all chemotherapy courses, patients randomized to arm I receive ImmTher IV over 60 minutes weekly for 1 year. Patients randomized to arm II receive no further therapy. Patients are followed every 6 weeks for 2 years.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within approximately 5 years.
- Conditions
- Sarcoma
- Being tested
- cyclophosphamide, dexrazoxane hydrochloride, disaccharide tripeptide glycerol dipalmitoyl, doxorubicin hydrochloride, vincristine sulfate
- Keywords
- nonmetastatic childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- Medical subject headings
- Sarcoma, Neuroectodermal Tumors, Primitive, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
dexrazoxane hydrochlorideDrug
disaccharide tripeptide glycerol dipalmitoylDrug
surgical procedureProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2004 (estimated)
- Study startSep 1998
- Primary completionAug 2000
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Paul A. Meyers, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003667
- Sponsor's protocol ID
- 98-074
- Other IDs
- CDR0000066764, ENDOREX-MSKCC-98074, MDA-ID-97198, NCI-G98-1487
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 25 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane With and Without ImmTher for Newly Diagnosed High Risk Ewing's Sarcoma
- ClinicalTrials.gov ID
- NCT00003667
- Acronym / sponsor ID
- 98-074
- Conditions
- Sarcoma
- Keywords
- nonmetastatic childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1998
- Primary completion
- Aug 2000 (actual)
- Study completion
- Aug 2000 (actual)
- First posted
- 24 Jun 2004 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without biological therapy in treating patients who have newly diagnosed high-risk Ewing's sarcoma.
Detailed description
OBJECTIVES: I. Compare the effects of dose intensive regimens of vincristine, doxorubicin, cyclophosphamide, and dexrazoxane with or without ImmTher (a muramyl dipeptide liposome) on the 2 year disease-free survival of patients with newly diagnosed high risk Ewing's sarcoma. II. Evaluate the feasibility and determine the toxicity of administering weekly ImmTher for 1 year to these patients. III. Determine which therapy is worthy of further evaluation.
OUTLINE: This is a randomized study. Patients are stratified according to the presence of bony metastases at diagnosis. Patients are randomized to one of two treatment arms. All patients receive dexrazoxane IV followed 30 minutes later by doxorubicin IV over 30 minutes on day 1, vincristine IV on day 1, and cyclophosphamide IV over 6 hours on days 1 and 2. Treatment is repeated every 3 weeks for 3-6 courses in the absence of disease progression or unacceptable toxicity. Patients are evaluated after course 3 and undergo surgery and/or radiation therapy. The next 3 courses of chemotherapy are administered after recovery from surgery/radiation therapy. Within 1 month after completion of all chemotherapy courses, patients randomized to arm I receive ImmTher IV over 60 minutes weekly for 1 year. Patients randomized to arm II receive no further therapy. Patients are followed every 6 weeks for 2 years.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within approximately 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| dexrazoxane hydrochloride | Drug | – |
| disaccharide tripeptide glycerol dipalmitoyl | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| vincristine sulfate | Drug | – |
| surgical procedure | Procedure or surgery | – |
| radiation therapy | 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 25 Jun 2013.
Related trials for Sarcoma
RecruitingPhase 2
A Multicenter Phase II Clinical Trial Evaluating 68Ga-HX01 Injection for PET/CT Imaging
Soft Tissue Sarcoma
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
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.
Paul A. Meyers, MD study chair
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclophosphamide, dexrazoxane hydrochloride and disaccharide tripeptide glycerol dipalmitoyl in people with Sarcoma, run by Memorial Sloan Kettering Cancer Center at 2 sites 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 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
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 25 Jun 2013.