Melanoma (Skin)Phase 2NCT00085579
Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase 2 study testing aldesleukin, sargramostim and adjuvant therapy in people with Melanoma (Skin), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- aldesleukin, sargramostim and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Mar 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Stage III or IV disease
- No primary ocular melanoma
- Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago
- Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible
- Patients whose second evaluation shows disease progression are eligible unless one of the following is true:
- Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN)
- LDH > ULN AND is higher than the patient's highest value before systemic chemotherapy
- Patient has developed a new tumor measuring > 1 cm in diameter
- Sum of the longest diameters of the existing tumor has increased > 20%
- Evaluable or measurable disease
- Not potentially curable by surgery
- No active CNS metastases
- Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- No active bleeding
Hepatic
- See Disease Characteristics
- Bilirubin ≤ 2.0 mg/dL
Renal
- Creatinine ≤ 1.2 mg/dL
Cardiovascular
- Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following:
- Normal exercise stress test
- Normal stress thallium test
- Normal comparable cardiac ischemia evaluation
- LVEF ≥ 40%
Other
- No active infection requiring treatment
- No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent antineoplastic biologic response modifier therapy
- No concurrent antineoplastic vaccine therapy
Chemotherapy
- See Disease Characteristics
- No concurrent antineoplastic chemotherapy
Endocrine therapy
- No concurrent steroidal antiemetics
- No concurrent systemic corticosteroids
Radiotherapy
- See Disease Characteristics
- No concurrent antineoplastic radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
- Surgery within the past 4 weeks allowed provided there is no evidence of disease progression
Other
- More than 4 weeks since prior therapy for melanoma
- No other concurrent antineoplastic experimental therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy
RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim (GM-CSF).
Secondary
- Determine the time to progression in patients treated with this regimen.
- Determine the effects of this regimen on lymphocyte subsets in these patients.
OUTLINE: Patients are stratified according to response to prior systemic chemotherapy (stable disease [SD] vs partial response [PR]).
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14 and low-dose interleukin-2 (IL-2) SC on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pulses of high-dose IL-2* IV continuously over 42 hours on days 1 and 2 of courses 2, 3, 5, 6, 8, 10 and 12.
NOTE: *Low-dose IL-2 and GM-CSF are not administered on days 1 and 2 of high-dose IL-2 administration
Patients who continue to have SD or a PR after 12 courses of therapy may continue to receive treatment with GM-CSF and low-dose IL-2 as described above and high-dose IL-2 on days 1 and 2 of every third course.
PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per stratum) will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- aldesleukin, sargramostim, adjuvant therapy
- Keywords
- stage III melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
sargramostimBiological
adjuvant therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startMar 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Paul B. Chapman, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterJedd D. Wolchok, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085579
- Sponsor's protocol ID
- 04-027
- Other IDs
- MSKCC-04027
- Status last verified
- Dec 2012
- First submitted
- 10 Jun 2004
- Last updated
- 12 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy
- ClinicalTrials.gov ID
- NCT00085579
- Acronym / sponsor ID
- 04-027
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 11 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 and sargramostim may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.
Detailed description
OBJECTIVES:
Primary
- Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim (GM-CSF).
Secondary
- Determine the time to progression in patients treated with this regimen.
- Determine the effects of this regimen on lymphocyte subsets in these patients.
OUTLINE: Patients are stratified according to response to prior systemic chemotherapy (stable disease [SD] vs partial response [PR]).
Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14 and low-dose interleukin-2 (IL-2) SC on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pulses of high-dose IL-2* IV continuously over 42 hours on days 1 and 2 of courses 2, 3, 5, 6, 8, 10 and 12.
NOTE: *Low-dose IL-2 and GM-CSF are not administered on days 1 and 2 of high-dose IL-2 administration
Patients who continue to have SD or a PR after 12 courses of therapy may continue to receive treatment with GM-CSF and low-dose IL-2 as described above and high-dose IL-2 on days 1 and 2 of every third course.
PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| aldesleukin | Biological | – |
| sargramostim | Biological | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
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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.
Paul B. Chapman, MD principal investigator
Memorial Sloan Kettering Cancer Center
Jedd D. Wolchok, MD principal investigator
Memorial Sloan Kettering 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 aldesleukin, sargramostim and adjuvant therapy in people with Melanoma (Skin), run by Memorial Sloan Kettering 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: withdrawn, as of the sponsor's last update on 12 Dec 2012. 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 was withdrawn before enrolling participants, so there are no results.
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 12 Dec 2012.