Brain and Central Nervous System TumorsPhase 2NCT00002965
Interferon Alfa in Treating Patients With Recurrent Unresectable Meningiomas and Malignant Meningiomas
A Phase 2 study testing Recombinant Interferon Alfa (INF alpha) in people with Brain and Central Nervous System Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
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 patients with recurrent unresectable meningiomas and malignant meningiomas. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- Recombinant Interferon Alfa (INF alpha)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1997to Mar 2003
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven tumors:
- Unresectable meningioma
- Atypical meningioma
- Malignant meningioma
- Angioblastic meningioma
- Hemangiopericytoma
- Recurrent or progressive, unresectable tumor after failing radiation therapy or refused radiation therapy following 2 surgeries
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Karnofsky at least 60%
Life expectancy:
- At least 3 months
Hematopoietic:
- AGC at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- SGPT less than 2.0 times normal
- Alkaline phosphatase less than 2.0 times normal
- Bilirubin less than 1.5 mg/dL
Renal:
- BUN less than 1.5 times normal OR
- Creatinine less than 1.5 times normal
Other:
- No active infection
- No diseases that obscure toxicity or dangerously alter drug metabolism
- No serious intercurrent medical illness
- Not pregnant
- Fertile patients must use adequate contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent biologic therapy
Chemotherapy:
- Prior chemotherapy allowed and recovered from all myelotoxicity secondary to the therapy
Endocrine therapy:
- Prior hormonal therapy allowed
- No concurrent hormonal therapy
Radiotherapy:
- Prior radiotherapy allowed
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas
RATIONALE: Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of interferon alfa in treating patients with recurrent unresectable meningiomas and malignant meningiomas.
Read the detailed description
OBJECTIVES:
- Evaluate the efficacy of recombinant interferon alpha (IFN alpha) as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas.
- Determine the nature and extent of central nervous system (CNS) toxicities associated with the use of alpha interferon in current doses and schedules.
OUTLINE: This is a two arm, randomized study. The first arm includes all histologically benign meningiomas. The second arm includes all other pathologies.
All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8 weeks. Treatment continues without interruption as long as there is no tumor recurrence or progression and toxicity is acceptable.
Treatment continues without dose adjustment for the first 8 weeks as long as there are no toxic effects of grade III or greater. Dosage for subsequent courses is one dose level below the dose that produced toxicity of grade III or greater.
PROJECTED ACCRUAL: 20 patients will be entered per year into each arm.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- Recombinant Interferon Alfa (INF alpha)
- Keywords
- recurrent adult brain tumor
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Interferon Alfa (INF alpha)Biological
Also called Roferon, Interferon Alfa, Alpha 2 Interferon, IFN alpha-2A
Subcutaneous injection Monday through Friday for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Benign Meningiomas | Experimental | INF alpha as a subcutaneous injection Monday to Friday for 8 weeks. Receives: Biological: Recombinant Interferon Alfa (INF alpha) |
| Arm 2: Other Pathologies | Experimental | INF alpha as subcutaneous injection Monday to Friday for 8 weeks. Receives: Biological: Recombinant Interferon Alfa (INF alpha) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Dose Limiting Toxicity (DLT)
Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).
Measured: Each 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2003 (estimated)
- Study startJan 1997
- Primary completionMar 2003
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Wai-Kwan A. Yung, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002965
- Sponsor's protocol ID
- DM96-296
- Other IDs
- P30CA016672, MDA-DM-96296, NCI-G97-1206, CDR0000065463
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy of Recombinant Interferon-Alpha in the Treatment of Recurrent Unresectable Meningiomas and Malignant Meningiomas
- ClinicalTrials.gov ID
- NCT00002965
- Acronym / sponsor ID
- DM96-296
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 1997
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 11 Jul 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 patients with recurrent unresectable meningiomas and malignant meningiomas.
Detailed description
OBJECTIVES:
- Evaluate the efficacy of recombinant interferon alpha (IFN alpha) as a single agent in the treatment of recurrent unresectable meningiomas and malignant meningiomas.
- Determine the nature and extent of central nervous system (CNS) toxicities associated with the use of alpha interferon in current doses and schedules.
OUTLINE: This is a two arm, randomized study. The first arm includes all histologically benign meningiomas. The second arm includes all other pathologies.
All patients receive INF alpha as a subcutaneous injection Monday through Friday for 8 weeks. Treatment continues without interruption as long as there is no tumor recurrence or progression and toxicity is acceptable.
Treatment continues without dose adjustment for the first 8 weeks as long as there are no toxic effects of grade III or greater. Dosage for subsequent courses is one dose level below the dose that produced toxicity of grade III or greater.
PROJECTED ACCRUAL: 20 patients will be entered per year into each arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Benign Meningiomas | Experimental | Biological: Recombinant Interferon Alfa (INF alpha)INF alpha as a subcutaneous injection Monday to Friday for 8 weeks. |
| Arm 2: Other Pathologies | Experimental | Biological: Recombinant Interferon Alfa (INF alpha)INF alpha as subcutaneous injection Monday to Friday for 8 weeks. |
Who may qualify
- Ages
- 16 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 |
|---|---|---|
| Recombinant Interferon Alfa (INF alpha)Also: Roferon, Interferon Alfa, Alpha 2 Interferon, IFN alpha-2ASubcutaneous injection Monday through Friday for 8 weeks. | Biological | Arm 1: Benign Meningiomas, Arm 2: Other Pathologies |
Primary outcome
Number of Patients with Dose Limiting Toxicity (DLT)
Time frame: Each 8 weeks
Efficacy of IFN alpha as single agent in treatment of recurrent unresectable/malignant meningiomas as measured by Dose Limiting Toxicities (DLT).
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 22 Dec 2023.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Wai-Kwan A. Yung, MD study chair
M.D. Anderson 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 2 study testing Recombinant Interferon Alfa (INF alpha) in people with Brain and Central Nervous System Tumors, run by M.D. Anderson 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 22 Dec 2023. 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 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?
Number of Patients with Dose Limiting Toxicity (DLT) (time frame: Each 8 weeks). 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 22 Dec 2023.