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Malignant Melanoma Stage IVPhase 1/2NCT00313235

Combined Modality Treatment for Patients With Stage IV Melanoma

A Phase 1/2 study testing DC Vaccine and Cyclophosphamide in people with Malignant Melanoma Stage IV, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test a combined treatment using cyclophosphamide and a novel dendritic cell vaccine in patients with Stage IV melanoma. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Malignant Melanoma Stage IV
What is being tested?
DC Vaccine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
Mar 2006to Jun 2012
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 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage M1a, M1b, M1c biopsy proven metastatic melanoma.
  • Ages 21-75.
  • Karnofsky performance status greater than/equal to 80%.
  • Measurable metastatic lesions by physical exam or scans.
  • Acceptable CBC and blood chemistry results.
  • Adequate hepatic and renal function.
  • No active CNS metastatic disease. If CNS history is present, lesions must have been resected by surgery and/or gamma knife irradiation at least 3 months prior to study entry. The total number of CNS lesions at diagnosis should not exceed 3.
  • Written informed consent.

Who cannot join

  • Patients that have received more than 8 cycles of chemotherapy for metastatic melanoma.
  • Patients who have received chemotherapy less than 4 weeks before beginning the trial.
  • Patients who have received IFN alpha-2b or GM-CSF less than 4 weeks before beginning the trial.
  • Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
  • Patients diagnosed with more than 3 CNS metastatic melanoma lesions.
  • More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
Show all 14Show fewer
  • Baseline serum LDH greater than 1.1 times the upper limit of normal.
  • Patients who are HIV positive.
  • Patients who are pregnant.
  • Patients who have receive corticosteroids or other agents less than 4 weeks before beginning the trial.
  • Patients with asthma, angina pectoris or congestive heart failure.
  • Patients with autoimmune disease such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
  • Patients with active infections including viral hepatitis.
  • Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor University Medical Center

    Dallas, Texas, 75246

Other trials in United States

About this study

Official title: Combined Modality Treatment for Patients With Stage IV Melanoma: Cyclophosphamide and a Dendritic Cell Vaccine Loaded With Killed Allogeneic Melanoma Cells

The purpose of this study is to test a combined treatment using cyclophosphamide and a novel dendritic cell vaccine in patients with Stage IV melanoma.

Read the detailed description

A novel dendritic cell vaccine is being developed at the Baylor Institute for Immunology Research. Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing a tumor specific immunity than other dendritic cell vaccines. Further studies in BIIR have been done with dendritic cells that were loaded with killed melanoma cells from a melanoma cell line treated with heat before loading. Both studies have shown that DCs manufactured in this novel way were more efficient in priming the melanoma specific CD8+ cells. Our previous studies indicate that a portion of patients with stage IV melanoma cannot mount an immune response to tumor antigens presented on dendritic cells. Also, regulatory/suppressor T cells can be identified in the blood of these patients, which may account for the lack of induction of T cell immunity to dendritic cell vaccines. Cyclophosphamide treatments have improved antitumor immunity in humans with melanoma and a clear relationship between cyclophosphamide dosage and suppressor cell activity has been documented. Therefore, this trial will test a combined modality treatment, using dendritic cell based vaccines in patients who have been treated with cyclophosphamide.

This clinical trial will evaluate the cyclophosphamide/dendritic cell vaccine in patients with Stage IV melanoma. The trial will accrue a total of 33 subjects. The primary goal of this trial will be to test the safety/tolerability/feasibility of the combined modality and the rate of objective clinical response.However if feasibility data in the first 10 subjects demonstrate the need to adjust the dose of CPA, the new dose will be tested in the next 10 subjects thereby extending the accrual to 43 subjects. A 15% objective response rate will be accepted in patients with stage IV Melanoma.

Patients will receive cyclophosphamide 300 mg/m2, administered 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Each subject will initially receive 7 doses of vaccination with each individual dose being administered at weeks 0, 2, 4, 6, 10, 14 and 18. A clinical evaluation of the patients will be done at weeks 10 \& 20. Patients with progressive disease will be taken off of the study. Patients with SD, PR or CD (according to RECIST criteria) may receive 4 more vaccinations. Scans and re-staging tests will be performed at scheduled intervals throughout the study.

Being tested
DC Vaccine and Cyclophosphamide
Keywords
Dendritic Vaccine, Melanoma, Cyclophosphamide (CPA)
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC Vaccine and CyclophosphamideBiological

    Also called Cyclophosphamide - CPA, Dendritic Cell Vaccine - DC Vaccine

    Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site).

    Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks.

    CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure.

Study groups in NCT00313235
Study groupRoleWhat they receive
DC Vaccine and CyclophosphamideExperimentalAutologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site). Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks. CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure.
Receives: Biological: DC Vaccine and Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of the combination of DC vaccination and CPA therapy in human subjects

    Measured: 2 Years

  2. Feasibility of this combination therapy

    Measured: 2 Years

  3. Objective clinical responses

    Measured: 2 Years

Secondary outcomes (2)

  1. Immunogenicity of DC vaccinations in subjects

    Measured: 2 Years

  2. Effect of CPA at this dose and schedule on the regulatory/suppressor T cells

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionJun 2011
  4. Study completionJun 2012

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313235
Sponsor's protocol ID
Baylor IRB #006-025-01
Other IDs
IND 12919
Status last verified
Jun 2013
First submitted
10 Apr 2006
Last updated
13 Jun 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DC Vaccine and Cyclophosphamide in people with Malignant Melanoma Stage IV, run by Baylor Research Institute 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?

The sponsor lists 8 inclusion and 14 exclusion criteria. 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 13 Jun 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 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 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?

Safety and tolerability of the combination of DC vaccination and CPA therapy in human subjects (time frame: 2 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00313235.

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 13 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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