Cardiac ToxicityPhase 3NCT00002827
Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease
A Phase 3 study testing bleomycin sulfate, filgrastim and dexrazoxane hydrochloride in people with Cardiac Toxicity and Lymphoma, run by Children's Oncology Group at 39 sites in 3 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Cardiac Toxicity, Lymphoma
- What is being tested?
- bleomycin sulfate, filgrastim and dexrazoxane hydrochloride
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 39 sitesin 3 countries
- Study dates
- Oct 1996to Jun 2008
- Phase
- Phase 3
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease No more than 5 weeks since diagnostic biopsy No B symptoms Clinical/pathologic stages (all histologies) as follows: Stage IA/IIA with mediastinal mass less than one third of chest diameter Stage IIIA limited to spleen or splenic, celiac, or portal nodes and lesions no larger than 6 cm Surgical staging required if: Clinical and imaging findings equivocal Tanner stage IV/V for whom radiotherapy is planned Concurrent registration on protocols POG-8828 (late effects study) and POG- 8829 (epidemiology study) required
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Hematopoietic: No hematopoietic disease Hepatic: No liver disease Renal: No renal disease Other: No severe organ or system damage or failure No pregnant or nursing women
PRIOR CONCURRENT THERAPY: No prior therapy
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
United States36 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
Children's Hospital of Denver
Denver, Colorado, 80218
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, 64108
Long Beach Memorial Medical Center
Long Beach, California, 90806
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Kaplan Cancer Center
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
Children's Hospital of Orange County
Orange, California, 92668
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
David Grant Medical Center
Travis Air Force Base, California, 94535
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
Canada2 sites
IWK Grace Health Centre
Halifax, Nova Scotia, B3J 3G9
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Australia1 site
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
About this study
Official title: RESPONSE DEPENDENT TREATMENT OF STAGES IA, IIA AND IIIA HODGKIN'S DISEASE WITH DBVE AND LOW DOSE INVOLVED FIELD IRRADIATION WITH OR WITHOUT ZINECARD: A PEDIATRIC ONCOLOGY GROUP PHASE III STUDY
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.
Read the detailed description
OBJECTIVES: I. Modify chemotherapy courses based on initial response to therapy in children with newly diagnosed stage IA/IIA/IIIA1 Hodgkin's disease. II. Examine the activity of variable courses of doxorubicin, bleomycin, vincristine, and etoposide (DBVE) followed by low-dose involved-field irradiation in these patients. III. Monitor the safety and feasibility of the response-dependent approach and the morbidity and immediate and long-term toxic effects associated with this regimen. IV. Assess whether limited therapy is adequate for patients with an early response. V. Evaluate whether the addition of dexrazoxane can reduce pulmonary toxicity while not significantly reducing the response rate or event-free survival. VI. Evaluate whether the frequency and magnitude of myocardial injury during therapy, as measured by elevated serum cardiac troponin-T, is reduced by the addition of dexrazoxane.
OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomly assigned to receive doxorubicin, bleomycin, vincristine, etoposide, and filgrastim with vs. without dexrazoxane. Filgrastim SC begins on days 6-13; no filgrastim is given on day 14 or 15. Filgrastim will restart 2 days after completing therapy and continue until count recovery from expected nadir (ANC greater than 1000 cubic meter after nadir). Courses repeat every 28 days. Those with stable or responding disease after 2-4 courses receive involved-field radiotherapy 5 days per week for 3.5 weeks. Tanner stage IV/V patients are eligible for randomization based on a front-end institutional agreement and may receive standard-field radiotherapy 5 days per week for up to 11 weeks at the investigator's discretion. Patients are followed yearly until relapse, death, or for a minimum of 10 years.
PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study over 5 years.
- Conditions
- Cardiac Toxicity, Lymphoma
- Being tested
- bleomycin sulfate, filgrastim, dexrazoxane hydrochloride, doxorubicin hydrochloride, etoposide
- Keywords
- stage II childhood Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, cardiac toxicity
- Medical subject headings
- Cardiotoxicity, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
Also called Blenoxane, NSC #125066
Given IV
filgrastimBiological
Also called Granulocyte-colony stimulating factor, r-metHuG-CSF, G-CSF, Neupogen
Given IV
dexrazoxane hydrochlorideDrug
Also called DZR, ADR-529, ZINECARD, ICRF-187
Given IV
Also called NSC #123127
Given IV
etoposideDrug
Also called VP-16, VePesid, NSC #141540
Given IV
Also called VCR, Oncovin, NSC #67574
Given IV
low-LET cobalt-60 gamma ray therapyRadiation
low-LET electron therapyRadiation
low-LET photon therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Treatment #1 (Without Zinecard) | Experimental | All patients undergoing a splenectomy must receive penicillin or erythromycin prophylaxis twice a day. Pneumocystis prophylaxis:TMP/SMZ 150mg/m2(maximum 300 mg) of TMP in 2 divided doses on 3 consecutive days each week. Aerosolized Pentamidine (200mg/m2/dose - maximum dose 300 mg) should be substituted monthly for patients who cannot tolerate TMP/SMZ therapy. Continue pneumocystis prophylaxis for 6 months after stopping therapy.
Doxorubicin hydrochloride 25mg/m2/day IV push over 15 minutes days 1 and 15 Bleomycin sulfate 10 IU/m2/day IV push over 10 minutes on days 1 and 15 Vincristine sulfate 1.5mg/m2/day IV push (maximum 2mg) days 1 and 15 Etoposide 10mg/m2/day 1-5. IV drip ( < 0.4mg/ml) over 1 hour. Monitor blood pressure every 15 minutes during infusion. G-CSF (filgrastim) 5 mcg/Kg/day start on day 6 (24-36 hrs after 5th dose of VP16) and continued through day 13 (total 8 days). Receives: Biological: bleomycin sulfate; Biological: filgrastim; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: vincristine sulfate; Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy |
| Treatment #2 (with Zinecard) | Experimental | Zinecard (DZR) 250 mg/m2 IV push on days 1 and 15 before administration of doxorubicin and bleomycin sulfate. Give bleomycin sulfate and doxorubicin within 30 minutes of Zinecard (dexrazoxane hydrochloride). Bleomycin 10 IU/m2/day IV push over 10 minutes on days 1 and 15 Doxorubicin hydrochloride 25mg/m2/day IV push over 15 minutes days 1 and 15 Vincristine Sulfate 1.5mg/m2/day IV push (maximum 2mg) days 1 and 15 Receives: Biological: bleomycin sulfate; Biological: filgrastim; Drug: dexrazoxane hydrochloride; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: vincristine sulfate; Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLCO
The Wilcoxon test will be used to evaluate whether DLCO values differ between the two arms.
Measured: 1 year post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2004 (estimated)
- Study startOct 1996
- Primary completionOct 2004
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac ToxicityStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Children's Cancer Group
- Responsible party
- Sponsor
- Investigators
- Cameron K. Tebbi, MD, Study chair, St. Joseph's Children's Hospital of TampaMichael A. Weiner, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002827
- Sponsor's protocol ID
- 9426
- Other IDs
- POG-9426, CCG-P9426, CDR0000065013, COG-9426
- Status last verified
- Aug 2013
- First submitted
- 1 Nov 1999
- Last updated
- 26 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tebbi CK, London WB, Friedman D, Villaluna D, De Alarcon PA, Constine LS, Mendenhall NP, Sposto R, Chauvenet A, Schwartz CL. Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. J Clin Oncol. 2007 Feb 10;25(5):493-500. doi: 10.1200/JCO.2005.02.3879.
PubMed 17290056Schwartz CL, Tebbi CK, Constine LS: Response based therapy for pediatric Hodgkin's disease (HD): Pediatric Oncology Group (POG) protocols 9425/9426. [Abstract] Med Pediatr Oncol 37 (3): A-P219, 263, 2001.
Tebbi CK, Mendenhall NP, London WB, Williams JL, Hutchison RE, Fitzgerald TJ, de Alarcon PA, Schwartz C, Chauvenet A. Response-dependent and reduced treatment in lower risk Hodgkin lymphoma in children and adolescents, results of P9426: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2012 Dec 15;59(7):1259-65. doi: 10.1002/pbc.24279. Epub 2012 Aug 21.
PubMed 22911615Mendenhall NP, Meyer J, Williams J, et al.: The impact of central quality assurance review prior to radiation therapy on protocol compliance: POG 9426, a trial in pediatric Hodgkin's disease. [Abstract] Blood 106 (11): A-753, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESPONSE DEPENDENT TREATMENT OF STAGES IA, IIA AND IIIA HODGKIN'S DISEASE WITH DBVE AND LOW DOSE INVOLVED FIELD IRRADIATION WITH OR WITHOUT ZINECARD: A PEDIATRIC ONCOLOGY GROUP PHASE III STUDY
- ClinicalTrials.gov ID
- NCT00002827
- Acronym / sponsor ID
- 9426
- Conditions
- Cardiac Toxicity, Lymphoma
- Keywords
- stage II childhood Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, cardiac toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI), Children's Cancer Group
- Study start
- Oct 1996
- Primary completion
- Oct 2004 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 26 May 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 cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known if chemotherapy is more effective with or without dexrazoxane for Hodgkin's disease.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, with or without dexrazoxane, followed by radiation therapy in treating young patients with newly diagnosed stage I, stage II, or stage III Hodgkin's disease.
Detailed description
OBJECTIVES: I. Modify chemotherapy courses based on initial response to therapy in children with newly diagnosed stage IA/IIA/IIIA1 Hodgkin's disease. II. Examine the activity of variable courses of doxorubicin, bleomycin, vincristine, and etoposide (DBVE) followed by low-dose involved-field irradiation in these patients. III. Monitor the safety and feasibility of the response-dependent approach and the morbidity and immediate and long-term toxic effects associated with this regimen. IV. Assess whether limited therapy is adequate for patients with an early response. V. Evaluate whether the addition of dexrazoxane can reduce pulmonary toxicity while not significantly reducing the response rate or event-free survival. VI. Evaluate whether the frequency and magnitude of myocardial injury during therapy, as measured by elevated serum cardiac troponin-T, is reduced by the addition of dexrazoxane.
OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomly assigned to receive doxorubicin, bleomycin, vincristine, etoposide, and filgrastim with vs. without dexrazoxane. Filgrastim SC begins on days 6-13; no filgrastim is given on day 14 or 15. Filgrastim will restart 2 days after completing therapy and continue until count recovery from expected nadir (ANC greater than 1000 cubic meter after nadir). Courses repeat every 28 days. Those with stable or responding disease after 2-4 courses receive involved-field radiotherapy 5 days per week for 3.5 weeks. Tanner stage IV/V patients are eligible for randomization based on a front-end institutional agreement and may receive standard-field radiotherapy 5 days per week for up to 11 weeks at the investigator's discretion. Patients are followed yearly until relapse, death, or for a minimum of 10 years.
PROJECTED ACCRUAL: A total of 285 patients will be accrued for this study over 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment #1 (Without Zinecard) | Experimental | Biological: bleomycin sulfate, Biological: filgrastim, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: vincristine sulfate, Radiation: low-LET cobalt-60 gamma ray therapy, Radiation: low-LET electron therapy, Radiation: low-LET photon therapyAll patients undergoing a splenectomy must receive penicillin or erythromycin prophylaxis twice a day. Pneumocystis prophylaxis:TMP/SMZ 150mg/m2(maximum 300 mg) of TMP in 2 divided doses on 3 consecutive days each week. Aerosolized Pentamidine (200mg/m2/dose - maximum dose 300 mg) should be substituted monthly for patients who cannot tolerate TMP/SMZ therapy. Continue pneumocystis prophylaxis for 6 months after stopping therapy. Doxorubicin hydrochloride 25mg/m2/day IV push over 15 minutes days 1 and 15 Bleomycin sulfate 10 IU/m2/day IV push over 10 minutes on days 1 and 15 Vincristine sulfate 1.5mg/m2/day IV push (maximum 2mg) days 1 and 15 Etoposide 10mg/m2/day 1-5. IV drip ( < 0.4mg/ml) over 1 hour. Monitor blood pressure every 15 minutes during infusion. G-CSF (filgrastim) 5 mcg/Kg/day start on day 6 (24-36 hrs after 5th dose of VP16) and continued through day 13 (total 8 days). |
| Treatment #2 (with Zinecard) | Experimental | Biological: bleomycin sulfate, Biological: filgrastim, Drug: dexrazoxane hydrochloride, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: vincristine sulfate, Radiation: low-LET cobalt-60 gamma ray therapy, Radiation: low-LET electron therapy, Radiation: low-LET photon therapyZinecard (DZR) 250 mg/m2 IV push on days 1 and 15 before administration of doxorubicin and bleomycin sulfate. Give bleomycin sulfate and doxorubicin within 30 minutes of Zinecard (dexrazoxane hydrochloride). Bleomycin 10 IU/m2/day IV push over 10 minutes on days 1 and 15 Doxorubicin hydrochloride 25mg/m2/day IV push over 15 minutes days 1 and 15 Vincristine Sulfate 1.5mg/m2/day IV push (maximum 2mg) days 1 and 15 |
Who may qualify
- Ages
- Up to 21 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 |
|---|---|---|
| bleomycin sulfateAlso: Blenoxane, NSC #125066Given IV | Biological | Treatment #1 (Without Zinecard), Treatment #2 (with Zinecard) |
| filgrastimAlso: Granulocyte-colony stimulating factor, r-metHuG-CSF, G-CSF, NeupogenGiven IV | Biological | Treatment #1 (Without Zinecard), Treatment #2 (with Zinecard) |
| dexrazoxane hydrochlorideAlso: DZR, ADR-529, ZINECARD, ICRF-187Given IV | Drug | Treatment #2 (with Zinecard) |
| doxorubicin hydrochlorideAlso: NSC #123127Given IV | Drug | Treatment #1 (Without Zinecard), Treatment #2 (with Zinecard) |
| etoposideAlso: VP-16, VePesid, NSC #141540Given IV | Drug | Treatment #1 (Without Zinecard), Treatment #2 (with Zinecard) |
| vincristine sulfateAlso: VCR, Oncovin, NSC #67574Given IV | Drug | Treatment #1 (Without Zinecard), Treatment #2 (with Zinecard) |
| low-LET cobalt-60 gamma ray therapy | Radiation | Treatment #1 (Without Zinecard), Treatment #2 (with Zinecard) |
| low-LET electron therapy | Radiation | Treatment #1 (Without Zinecard), Treatment #2 (with Zinecard) |
| low-LET photon therapy | Radiation | Treatment #1 (Without Zinecard), Treatment #2 (with Zinecard) |
Primary outcome
DLCO
Time frame: 1 year post therapy
The Wilcoxon test will be used to evaluate whether DLCO values differ between the two arms.
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 26 Aug 2013.
- Background: PubMed 17290056Tebbi CK, London WB, Friedman D, Villaluna D, De Alarcon PA, Constine LS, Mendenhall NP, Sposto R, Chauvenet A, Schwartz CL. Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. J Clin Oncol. 2007 Feb 10;25(5):493-500. doi: 10.1200/JCO.2005.02.3879.
- BackgroundSchwartz CL, Tebbi CK, Constine LS: Response based therapy for pediatric Hodgkin's disease (HD): Pediatric Oncology Group (POG) protocols 9425/9426. [Abstract] Med Pediatr Oncol 37 (3): A-P219, 263, 2001.
- Results publication: PubMed 22911615Tebbi CK, Mendenhall NP, London WB, Williams JL, Hutchison RE, Fitzgerald TJ, de Alarcon PA, Schwartz C, Chauvenet A. Response-dependent and reduced treatment in lower risk Hodgkin lymphoma in children and adolescents, results of P9426: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2012 Dec 15;59(7):1259-65. doi: 10.1002/pbc.24279. Epub 2012 Aug 21.
- Results publicationMendenhall NP, Meyer J, Williams J, et al.: The impact of central quality assurance review prior to radiation therapy on protocol compliance: POG 9426, a trial in pediatric Hodgkin's disease. [Abstract] Blood 106 (11): A-753, 2005.
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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.
Cameron K. Tebbi, MD study chair
St. Joseph's Children's Hospital of Tampa
Michael A. Weiner, MD study chair
Herbert Irving Comprehensive Cancer Center
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bleomycin sulfate, filgrastim and dexrazoxane hydrochloride in people with Cardiac Toxicity and Lymphoma, run by Children's Oncology Group at 39 sites in 3 countries.
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 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada, Australia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
DLCO (time frame: 1 year post therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002827, which also lists 4 linked publications.
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 26 Aug 2013.