Melanoma (Skin)Phase 2NCT00004141
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
A Phase 2 study testing Cisplatin, dacarbazine and Granulocyte-macrophage colony-stimulating factor in people with Melanoma (Skin), run by University of Chicago at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- Cisplatin, dacarbazine and Granulocyte-macrophage colony-stimulating factor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Apr 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma
- Stage III with intransit metastases
- Stage IV
- No uncontrolled brain metastases by CT scan
- No clinically significant ascites or pleural effusions
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 10 weeks
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.5 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT no greater than 4 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 70 mL/min
Cardiovascular:
- No clinically significant cardiac disease on EKG, echocardiogram, or MUGA scan
Pulmonary:
- No clinically significant pulmonary disease on chest x-ray
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant thyroid dysfunction
- No concurrent severe infection
- No other medical or psychiatric condition that would interfere with compliance
- No second malignancy within the past 5 years, except:
- Localized nonmelanomatous skin cancer
- Carcinoma in situ of the cervix
- Grade 1 Ta bladder cancer
- Suspected hearing deficits must undergo audiologic testing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No more than one prior immunotherapy regimen
- At least 4 weeks since prior immunotherapy
- Adjuvant interferon alfa before relapse allowed
Chemotherapy:
- No more than one prior chemotherapy regimen
- At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
- No concurrent cyclophosphamide
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent corticosteroids or cyclosporine A
Radiotherapy:
- At least 2 weeks since prior radiotherapy
Surgery:
- At least 3 weeks since major surgery
Other:
- No concurrent immunosuppressive drugs
- No other concurrent investigational antineoplastic drugs
- Concurrent thyroid replacement therapy allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
About this study
Official title: Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one drug with different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma.
Read the detailed description
OBJECTIVES:
- Determine the toxicity of cisplatin and dacarbazine followed by sargramostim (GM-CSF), interferon alfa, and interleukin-2 in patients with metastatic melanoma.
- Determine the objective response rate, relapse free survival, and overall survival of these patients on this regimen.
OUTLINE: Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes sequentially on day 1, followed by sargramostim (GM-CSF) subcutaneously (SC) on days 2-7, interleukin-2 SC on days 8-14, and interferon alfa SC on days 8, 10, 12, and 14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression, and then every 8-12 weeks thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within 3 years.
- Conditions
- Melanoma (Skin)
- Being tested
- Cisplatin, dacarbazine, Granulocyte-macrophage colony-stimulating factor
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called CDDP
dacarbazineDrug
Also called DTIC
Granulocyte-macrophage colony-stimulating factorDrug
Also called GM-CSF
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | CDDP (75 mg/m2) and DTIC (660 mg/m2) will be administered sequentially by intravenous infusion in day 1. Subsequently, GM-CSF (450 mg/ m2) will be administered SC days 2-7; IL-2 (11 MU daily) will be given SC days 8-14, and IFN-2b (9 MU) will be given SC days 8, 10, 12, and 14. Receives: Drug: Cisplatin; Drug: dacarbazine; Drug: Granulocyte-macrophage colony-stimulating factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 1998
- Primary completionJan 2003
- Study completionApr 2006
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 University of ChicagoThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas F. Gajewski, MD, PhD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004141
- Sponsor's protocol ID
- 9372
- Other IDs
- UCCRC-9372, UCCRC-CTRC-9821, NCI-G99-1615
- Status last verified
- Sep 2013
- First submitted
- 10 Dec 1999
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF, IFN-a2b, and IL-2 in Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00004141
- Acronym / sponsor ID
- 9372
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1998
- Primary completion
- Jan 2003 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 27 Jan 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining more than one drug with different types of biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma.
Detailed description
OBJECTIVES:
- Determine the toxicity of cisplatin and dacarbazine followed by sargramostim (GM-CSF), interferon alfa, and interleukin-2 in patients with metastatic melanoma.
- Determine the objective response rate, relapse free survival, and overall survival of these patients on this regimen.
OUTLINE: Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes sequentially on day 1, followed by sargramostim (GM-CSF) subcutaneously (SC) on days 2-7, interleukin-2 SC on days 8-14, and interferon alfa SC on days 8, 10, 12, and 14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression, and then every 8-12 weeks thereafter.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Cisplatin, Drug: dacarbazine, Drug: Granulocyte-macrophage colony-stimulating factorCDDP (75 mg/m2) and DTIC (660 mg/m2) will be administered sequentially by intravenous infusion in day 1. Subsequently, GM-CSF (450 mg/ m2) will be administered SC days 2-7; IL-2 (11 MU daily) will be given SC days 8-14, and IFN-2b (9 MU) will be given SC days 8, 10, 12, and 14. |
Who may qualify
- 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 |
|---|---|---|
| CisplatinAlso: CDDP | Drug | Arm A |
| dacarbazineAlso: DTIC | Drug | Arm A |
| Granulocyte-macrophage colony-stimulating factorAlso: GM-CSF | Drug | Arm A |
Primary outcome
Objective response rate
Time frame: 2 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 5 Sep 2013.
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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.
Thomas F. Gajewski, MD, PhD study chair
University of Chicago
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 Cisplatin, dacarbazine and Granulocyte-macrophage colony-stimulating factor in people with Melanoma (Skin), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. 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?
Objective response rate (time frame: 2 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 5 Sep 2013.