Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00003009
Inhaled Interleukin-2 in Treating Patients With Metastatic or Unresectable Cancer
A Phase 1 study testing aldesleukin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Southern California at 1 site in United States.
Trial summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Giving interleukin-2 in different ways may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of inhaled interleukin-2 in treating patients with metastatic or unresectable cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- aldesleukin
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1996to Aug 2000
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed unresectable or metastatic cancer Confirmed by biopsy or fine needle aspiration Tumors must predominantly involve the lung Measurable or evaluable disease No lymphomas or leukemias No AIDS associate Kaposi's Sarcoma No uncontrolled brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-1 Life expectancy: At least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count within normal limits Hepatic: Bilirubin no greater than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Adequate cardiovascular system with NYHA Class 0 or I No uncontrolled cardiac arrhythmias Pulmonary: FEV1 at least 65% of predicted FVC at least 65% of predicted No asthma or bronchial obstruction that would prevent the delivery of IL-2 to all lobes of the lung Other: HIV negative No medical or psychological criteria that would make patient unable to tolerate the treatment Not pregnant or nursing Adequate contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interleukin-2 Prior biologic response therapy allowed No chronic use of immunosuppressive medicines Chemotherapy: Prior chemotherapy allowed Endocrine therapy: No chronic steroid use Prior hormonal therapy allowed Radiotherapy: No prior or concurrent radiotherapy except as palliative to areas of painful metastases outside the lung Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
About this study
Official title: A Phase I Study of Inhalation of Interleukin-2 (IL-2) in Patients With Metastatic or Unresectable Cancer
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Giving interleukin-2 in different ways may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of inhaled interleukin-2 in treating patients with metastatic or unresectable cancer.
Read the detailed description
OBJECTIVES: I. Define the safe and tolerance of an inhaled interleukin-2 (IL-2) administered once or twice a day. II. Determine blood levels of IL-2 and whether there is detectable stimulation of immune cells in patients receiving inhalation IL-2. III. Determine whether there is any shrinkage of pulmonary lesions of patients treated on this study.
OUTLINE: This is a two arm, escalating dose study of interleukin-2 (IL-2). In Arm I patients in cohorts of 3-6 are administered daily inhalations of IL-2 over 15 minutes on Monday through Friday for 4 consecutive weeks. At least 3 patients are treated at each dose level, and all patients in a cohort are observed for at least 2 weeks before escalating to a higher dose in absence of dose limiting toxicity. Escalation stops when maximum tolerated dose (MTD) is determined. In Arm II the initial dose is 25 percent of the MTD determined in Arm I administered by inhalation twice daily on Monday through Friday for 4 weeks. Subsequent patient cohorts receive doses escalated by 33 percent above the previous dose level. Responding patients continue treatment cycles of 4 weeks with 2 weeks of rest until they develop progressive disease or intolerable toxicity. Stable patients may stay on treatment for a maximum of 4 cycles.
PROJECTED ACCRUAL: A minimum of 12-15 and a maximum of 30 patients will be accrued for this study.
- Being tested
- aldesleukin
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2004 (estimated)
- Study startFeb 1996
- Primary completionAug 2000
- Study completionAug 2000
Why it stopped: Insufficient Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Raymond A. Kempf, MD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003009
- Sponsor's protocol ID
- CDR0000065584 (0I-95-1)
- Other IDs
- LAC-USC-0I951, NCI-G97-1264
- Status last verified
- May 2014
- First submitted
- 1 Nov 1999
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Inhalation of Interleukin-2 (IL-2) in Patients With Metastatic or Unresectable Cancer
- ClinicalTrials.gov ID
- NCT00003009
- Acronym / sponsor ID
- CDR0000065584 (0I-95-1)
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1996
- Primary completion
- Aug 2000 (actual)
- Study completion
- Aug 2000 (actual)
- First posted
- 16 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: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Giving interleukin-2 in different ways may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of inhaled interleukin-2 in treating patients with metastatic or unresectable cancer.
Detailed description
OBJECTIVES: I. Define the safe and tolerance of an inhaled interleukin-2 (IL-2) administered once or twice a day. II. Determine blood levels of IL-2 and whether there is detectable stimulation of immune cells in patients receiving inhalation IL-2. III. Determine whether there is any shrinkage of pulmonary lesions of patients treated on this study.
OUTLINE: This is a two arm, escalating dose study of interleukin-2 (IL-2). In Arm I patients in cohorts of 3-6 are administered daily inhalations of IL-2 over 15 minutes on Monday through Friday for 4 consecutive weeks. At least 3 patients are treated at each dose level, and all patients in a cohort are observed for at least 2 weeks before escalating to a higher dose in absence of dose limiting toxicity. Escalation stops when maximum tolerated dose (MTD) is determined. In Arm II the initial dose is 25 percent of the MTD determined in Arm I administered by inhalation twice daily on Monday through Friday for 4 weeks. Subsequent patient cohorts receive doses escalated by 33 percent above the previous dose level. Responding patients continue treatment cycles of 4 weeks with 2 weeks of rest until they develop progressive disease or intolerable toxicity. Stable patients may stay on treatment for a maximum of 4 cycles.
PROJECTED ACCRUAL: A minimum of 12-15 and a maximum of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| aldesleukin | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
Raymond A. Kempf, MD study chair
University of Southern California
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 aldesleukin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Southern California 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: stopped early, as of the sponsor's last update on 22 May 2014. 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 was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
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 22 May 2014.