Stage IV MelanomaPhase 1/2NCT00003552
Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Melanoma
A Phase 1/2 study testing allogeneic lymphocytes, anti-thymocyte globulin and cyclophosphamide in people with Stage IV Melanoma and Recurrent Melanoma, run by National Heart, Lung, and Blood Institute (NHLBI) 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. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stage IV Melanoma, Recurrent Melanoma
- What is being tested?
- allogeneic lymphocytes, anti-thymocyte globulin and cyclophosphamide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Oct 2002
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically confirmed metastatic melanoma not amenable to complete surgical resection and progressive despite immunotherapy and/or chemotherapy Bidimensionally evaluable clinically or radiographically HLA 6/6 or 5/6 matched sibling donor available No CNS metastases --Prior/Concurrent Therapy-- See Disease Characteristics At least 30 days since prior treatment for melanoma --Patient Characteristics-- Age: 18 to 60 Performance status: ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 4 mg/dL Transaminases no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: Left ventricular ejection fraction greater than 40% Pulmonary: DLCO greater than 65% of predicted Other: HIV negative No major organ dysfunction precluding transplantation No other malignancies except basal cell or squamous cell skin cancer No psychiatric disorder or mental deficiency that would preclude study Not pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung, and Blood Institute
Bethesda, Maryland, 20892
About this study
Official title: Phase I/II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation Followed by Allogeneic T-cell Infusion as Adoptive Immunotherapy in Patients With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients with metastatic melanoma.
Read the detailed description
OBJECTIVES: I. Identify an antitumor effect of allogeneic peripheral blood stem cell transplantation (PBSCT) in patients with metastatic melanoma.
II. Evaluate the safety and toxicity of a nonmyeloablative, low intensity, preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients.
III. Monitor engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in these patients.
IV. Investigate the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in this patient population.
- Investigate the effect of lymphocyte infusions on donor-host chimerism in this patient population.
VI. Determine disease-free survival, overall survival, and mortality from the procedure or tumor progression in this patient population.
PROTOCOL OUTLINE: This is a dose-escalation study of a conditioning regimen. Patients receive 1 of 3 dose levels of chemotherapy prior to peripheral blood progenitor cell (PBPC) transplantation. Patients at dose level 1 receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes daily on days -5 to -1. Patients at dose level 2 receive cyclophosphamide IV over 1 hour on days -7 and -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2. Patients at dose level 3 receive cyclophosphamide IV over 1 hour daily on days -8 to -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2.
Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2 if deemed necessary.
Patients with progressive disease on days 15-30, day 60, or day 100, without graft-versus-host disease, receive infusion(s) of donor lymphocytes. Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician.
Patients are followed every 2 months for 6 months, every 3 months for the next 2 years, and then every 6 months until year 5 posttransplantation.
PROJECTED ACCRUAL:
A total of 40 patients will be accrued for this study.
- Conditions
- Stage IV Melanoma, Recurrent Melanoma
- Being tested
- allogeneic lymphocytes, anti-thymocyte globulin, cyclophosphamide, fludarabine
- Keywords
- adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage IV melanoma, stage, melanoma
- Medical subject headings
- Melanoma, Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic lymphocytesDrug
anti-thymocyte globulinDrug
cyclophosphamideDrug
fludarabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startJan 1999
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV MelanomaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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 1/2
- Primary purpose
- Treatment
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Richard W. Childs, Study chair, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003552
- Sponsor's protocol ID
- CDR0000066609
- Other IDs
- NHLBI-98-H-0006
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2007
- Last updated
- 4 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation Followed by Allogeneic T-cell Infusion as Adoptive Immunotherapy in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00003552
- Acronym / sponsor ID
- CDR0000066609
- Conditions
- Stage IV Melanoma, Recurrent Melanoma
- Keywords
- adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage IV melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1999
- Study completion
- Oct 2002 (actual)
- First posted
- 5 Mar 2007 (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. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients with metastatic melanoma.
Detailed description
OBJECTIVES: I. Identify an antitumor effect of allogeneic peripheral blood stem cell transplantation (PBSCT) in patients with metastatic melanoma.
II. Evaluate the safety and toxicity of a nonmyeloablative, low intensity, preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients.
III. Monitor engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in these patients.
IV. Investigate the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in this patient population.
- Investigate the effect of lymphocyte infusions on donor-host chimerism in this patient population.
VI. Determine disease-free survival, overall survival, and mortality from the procedure or tumor progression in this patient population.
PROTOCOL OUTLINE: This is a dose-escalation study of a conditioning regimen. Patients receive 1 of 3 dose levels of chemotherapy prior to peripheral blood progenitor cell (PBPC) transplantation. Patients at dose level 1 receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes daily on days -5 to -1. Patients at dose level 2 receive cyclophosphamide IV over 1 hour on days -7 and -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2. Patients at dose level 3 receive cyclophosphamide IV over 1 hour daily on days -8 to -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2.
Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2 if deemed necessary.
Patients with progressive disease on days 15-30, day 60, or day 100, without graft-versus-host disease, receive infusion(s) of donor lymphocytes. Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician.
Patients are followed every 2 months for 6 months, every 3 months for the next 2 years, and then every 6 months until year 5 posttransplantation.
PROJECTED ACCRUAL:
A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- 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 |
|---|---|---|
| allogeneic lymphocytes | Drug | – |
| anti-thymocyte globulin | Drug | – |
| cyclophosphamide | Drug | – |
| fludarabine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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.
Richard W. Childs study chair
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing allogeneic lymphocytes, anti-thymocyte globulin and cyclophosphamide in people with Stage IV Melanoma and Recurrent Melanoma, run by National Heart, Lung, and Blood Institute (NHLBI) 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 4 Mar 2024. 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 combined 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.
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 stopped early. 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 4 Mar 2024.