LeukemiaPhase 2NCT00002621
Interferon Alfa in Treating Children With HIV-Related Cancer
A Phase 2 study testing recombinant interferon alfa in people with Leukemia and Lymphoma, run by Children's Oncology Group at 10 sites in 4 countries.
Trial summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating children with an HIV-related cancer including leukemia, non-Hodgkin's lymphoma, CNS lymphoma, or other solid tumors. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Leukemia, Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- recombinant interferon alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Dec 1994to Sep 2005
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically proven malignancy diagnosed at any time following confirmation of HIV-positivity, including the following:
- Leukemia
- Non-Hodgkin's lymphoma
- CNS lymphoma
- Other solid tumors
- Measurable disease
- Concurrent registration on protocol POG-9182 required
- Confirmed HIV-positive by POG-9182 criteria
- Required biology studies completed
PATIENT CHARACTERISTICS:
Age:
- 21 and under
Performance status:
- Not specified
Life expectancy:
- More than 4 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3 (unless bone marrow involvement present)
Hepatic:
- See Disease Characteristics
- Bilirubin less than 1.5 times normal
- SGPT and SGOT less than 2 times normal (may discuss with Study Coordinator)
Renal:
- Creatinine less than 1.5 mg/dL
Cardiovascular:
- Adequate cardiac function by echocardiogram/MUGA scan
Other:
- Chronically infected patients must be stable enough to meet life expectancy requirement
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior interferon for cancer
- Prior interferon alfa for viral infections (i.e., hepatitis) must be discussed with Study Coordinator
Chemotherapy:
- At least 1 week since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 1 week since prior radiotherapy
Surgery:
- Not specified
Other:
- Prior antiretroviral therapy allowed
- At least 1 week since prior acute treatment for any serious or life-threatening infection
- No concurrent local treatment unless discussed with the Study Coordinator
- No concurrent acute treatment for any serious or life-threatening infection
- Concurrent antiretroviral therapy allowed
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States7 sites
Mission Saint Joseph's Health System
Asheville, North Carolina, 28801
Medical City Dallas Hospital
Dallas, Texas, 75230
Tomorrows Children's Institute
Hackensack, New Jersey, 07601
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
Via Christi Regional Medical Center
Wichita, Kansas, 67214
Canada1 site
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Puerto Rico1 site
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, 00936-5067
About this study
Official title: A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating children with an HIV-related cancer including leukemia, non-Hodgkin's lymphoma, CNS lymphoma, or other solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa.
- Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients.
OUTLINE:
- Induction: Patients receive interferon alfa subcutaneously (SC) daily on days 1-14. Patients with advanced stage III or IV undifferentiated lymphomas or B-cell acute lymphoblastic leukemia also receive hydrocortisone intrathecally (IT) combined with cytarabine IT on day 14.
- Maintenance: Patients with stable or responding disease after completion of induction receive interferon alfa SC 3 times a week beginning on week 1. Treatment continues for a minimum of 4-12 weeks in the absence of disease progression or unacceptable toxicity. Patients who received IT therapy during induction receive the same IT therapy at 4, 8, and 12 weeks and then every 8 weeks thereafter.
Patients are followed every 6 months for 4 years and then annually for survival until entry on another POG protocol.
PROJECTED ACCRUAL: A total of 14-30 evaluable patients will be accrued for this study within 4.2 years.
- Being tested
- recombinant interferon alfa
- Keywords
- recurrent childhood acute lymphoblastic leukemia, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, unspecified childhood solid tumor, protocol specific, untreated childhood acute myeloid leukemia and other myeloid malignancies, untreated childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia in remission, childhood acute lymphoblastic leukemia in remission, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, stage I childhood small noncleaved cell lymphoma, stage I childhood large cell lymphoma, stage II childhood small noncleaved cell lymphoma, stage II childhood large cell lymphoma, stage III childhood small noncleaved cell lymphoma, stage III childhood large cell lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
Also called Intron A, Roferon A, NSC 377523
| Study group | Role | What they receive |
|---|---|---|
| Alpha interferon (aIFN) treatment | Experimental | See detailed description. Receives: Biological: recombinant interferon alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate for HIV related malignancies treated with interferon
Measured: Length of study
Secondary outcomes (1)
Event Free Survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2003 (estimated)
- Study startDec 1994
- Primary completionJul 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- V. M. Whitehead, MD, Study chair, Montreal Children's Hospital at McGill University Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002621
- Sponsor's protocol ID
- 9362
- Other IDs
- POG-9362, CDR0000063972
- Status last verified
- Jul 2014
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Alpha Interferon (alphaIFN) In HIV-Related Malignancies - A Pediatric Oncology Group Wide Study
- ClinicalTrials.gov ID
- NCT00002621
- Acronym / sponsor ID
- 9362
- Keywords
- recurrent childhood acute lymphoblastic leukemia, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood acute myeloid leukemia, unspecified childhood solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1994
- Primary completion
- Jul 2002 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 11 Aug 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: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating children with an HIV-related cancer including leukemia, non-Hodgkin's lymphoma, CNS lymphoma, or other solid tumors.
Detailed description
OBJECTIVES:
- Determine the complete response rate and one-year disease free survival of pediatric patients with HIV-related malignancies treated with interferon alfa.
- Determine the toxicity of interferon alfa alone and in combination with antiretroviral therapy in these patients.
OUTLINE:
- Induction: Patients receive interferon alfa subcutaneously (SC) daily on days 1-14. Patients with advanced stage III or IV undifferentiated lymphomas or B-cell acute lymphoblastic leukemia also receive hydrocortisone intrathecally (IT) combined with cytarabine IT on day 14.
- Maintenance: Patients with stable or responding disease after completion of induction receive interferon alfa SC 3 times a week beginning on week 1. Treatment continues for a minimum of 4-12 weeks in the absence of disease progression or unacceptable toxicity. Patients who received IT therapy during induction receive the same IT therapy at 4, 8, and 12 weeks and then every 8 weeks thereafter.
Patients are followed every 6 months for 4 years and then annually for survival until entry on another POG protocol.
PROJECTED ACCRUAL: A total of 14-30 evaluable patients will be accrued for this study within 4.2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha interferon (aIFN) treatment | Experimental | Biological: recombinant interferon alfaSee detailed description. |
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 |
|---|---|---|
| recombinant interferon alfaAlso: Intron A, Roferon A, NSC 377523 | Biological | Alpha interferon (aIFN) treatment |
Primary outcome
Complete response rate for HIV related malignancies treated with interferon
Time frame: Length of study
1 secondary outcome
Event Free Survival
Time frame: 1 year
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 24 Jul 2014.
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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.
V. M. Whitehead, MD study chair
Montreal Children's Hospital at McGill University Health Center
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alfa in people with Leukemia and Lymphoma, run by Children's Oncology Group at 10 sites in 4 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Puerto Rico, Switzerland. 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.
What does the primary outcome measure?
Complete response rate for HIV related malignancies treated with interferon (time frame: Length of study). It is what the study was designed to measure, not a finding.
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 24 Jul 2014.