Breast CancerPhase 1IFNaNCT00276536
Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma
A Phase 1 study testing recombinant interferon alpha-1b and IFN in people with Breast Cancer and Kidney Cancer, run by The Cleveland Clinic at 1 site in United States.
Trial summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer, Kidney Cancer, Lymphoma
- What is being tested?
- recombinant interferon alpha-1b and IFN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Jan 2004
- Phase
- Phase 1
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy, including, but not limited to, renal cell carcinoma, melanoma, Kaposi's sarcoma, breast carcinoma, lymphoma, myeloma, or tumors of endothelial origin
- Stage IV disease
- Refractory to standard therapy
- Measurable or evaluable disease
- Evaluable disease can include clinically or radiographically nonmeasurable tumor or specific tumor markers
- Patients with prior solitary CNS metastasis allowed
- Must have had prior definitive therapy ≥ 3 months previously
- No requirement for glucocorticoids unless for physiologic replacement
- No multiple CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.3 times upper limit of normal (ULN) OR
- Creatinine clearance of 60 mL/min
- Bilirubin ≤ 1.3 times ULN
- AST ≤ 5 times ULN
- No pregnant or lactating women
- Fertile women and men, unless surgically sterile, must use effective contraception
- No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
- No congestive heart failure
- No angina pectoris
- No New York Heart Association class III or IV disease
- No other severe cardiovascular disease
- No known seizure disorder
- No known HIV or hepatitis B surface antigen positivity
- No active clinical infection requiring antibiotics within the past 7 days
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 months since prior interferon therapy and/or ≤ 400 million units of interferon
- At least 3 weeks since prior major surgery requiring general anesthesia
- At least 3 weeks since prior radiotherapy or chemotherapy
- Treatment with hormones or other chemotherapeutic agents may not be administered except for steroids given for preexisting adrenal failure or hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
- No prior organ allograft
- No concurrent dexamethasone, other steroidal antiemetics, or anti-inflammatories
- No concurrent palliative radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195-5044
About this study
Official title: Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma
RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma.
Read the detailed description
OBJECTIVES:
- Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma.
- Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous injection in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
- Conditions
- Breast Cancer, Kidney Cancer, Lymphoma, Melanoma, Multiple Myeloma, Sarcoma
- Being tested
- recombinant interferon alpha-1b, IFN
- Keywords
- stage IV melanoma, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Breast Neoplasms, Kidney Neoplasms, Lymphoma, Melanoma, Multiple Myeloma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alpha-1bBiological
Also called Interferon
interferon
IFNDrug
Also called Interferon
IFN daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | IFN weekly Receives: Biological: recombinant interferon alpha-1b; Drug: IFN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJan 2001
- Primary completionJan 2004
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ernest C. Borden, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276536
- Sponsor's protocol ID
- CASE-CCF-3575
- Other IDs
- P30CA043703, CASE-CCF-3575
- Acronym
- IFNa
- Status last verified
- Oct 2015
- First submitted
- 12 Jan 2006
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma
- ClinicalTrials.gov ID
- NCT00276536
- Acronym / sponsor ID
- IFNa / CASE-CCF-3575
- Conditions
- Breast Cancer, Kidney Cancer, Lymphoma, Melanoma, Multiple Myeloma, Sarcoma
- Keywords
- stage IV melanoma, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2001
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 13 Jan 2006 (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 and slow the growth of cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma.
Detailed description
OBJECTIVES:
- Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma.
- Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous injection in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of interferon alfa-1b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: recombinant interferon alpha-1b, Drug: IFNIFN weekly |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 alpha-1bAlso: Interferoninterferon | Biological | Treatment |
| IFNAlso: InterferonIFN daily | Drug | Treatment |
Primary outcome
Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course
Time frame: 3 years
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 14 Oct 2015.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Ernest C. Borden, MD study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant interferon alpha-1b and IFN in people with Breast Cancer and Kidney Cancer, run by The Cleveland Clinic 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 14 Oct 2015. 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 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.
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?
Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course (time frame: 3 years). 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 14 Oct 2015.