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Kidney CancerPhase 1NCT00096629

Vaccine Therapy in Treating Patients With Kidney Cancer

A Phase 1 study testing human prostate-specific membrane antigen plasmid DNA vaccine and mouse prostate-specific membrane antigen plasmid DNA vaccine in people with Kidney Cancer, run by Memorial Sloan Kettering Cancer Center 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

RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with kidney cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
human prostate-specific membrane antigen plasmid DNA vaccine and mouse prostate-specific membrane antigen plasmid DNA vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Nov 2003to Apr 2018
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 renal cell carcinoma
  • Patients with minimal disease burden are eligible provided they meet one or more of the following criteria:
  • Prior nephrectomy and completely resected metastases
  • Favorable-risk group, as defined by all of the following criteria:
  • Karnofsky 80-100%
  • Hemoglobin ≥ 13 g/dL (male) or ≥ 12 g/dL (female)
  • Corrected calcium ≤ 10 mg/dL
  • Prior nephrectomy
  • Serum lactate dehydrogenase ≤ 200 μ/L
  • Prior nephrectomy with metastases confined to lung and/or small volume metastatic disease (< 3 cm) exclusive of bone and liver
  • No spinal, epidural, or CNS lesions
  • No bone, liver or brain disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • See Disease Characteristics
  • Karnofsky 80-100%

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • WBC ≥ 3,500/mm^3
  • Hemoglobin ≥ 12.0 g/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < 2.0 mg/dL
  • SGOT < 3.0 times upper limit of normal

Renal

  • See Disease Characteristics
  • Creatinine ≤ 2.0 mg/dL OR
  • Creatinine clearance ≥ 40 mL/min

Cardiovascular

  • No clinically significant cardiac disease
  • No New York Heart Association class III or IV heart disease

Pulmonary

  • No severe debilitating pulmonary disease

Other

  • Fertile patients must use effective contraception
  • No other active secondary malignancy within the past 5 years except non-melanoma skin cancer
  • No infection requiring antibiotic treatment
  • No narcotic- or steroid-dependent pain

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy

Endocrine therapy

  • At least 4 weeks since prior corticosteroid therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy to only measurable lesion

Surgery

  • See Disease Characteristics
  • No concurrent surgery

Other

  • Recovered from all prior therapy
  • No other concurrent anticancer therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: Injection of Renal Cell Carcinoma Patients With Human and Mouse Prostate Specific Membrane Antigen (PSMA) DNA: A Phase I Trial to Assess Safety and Immune Response

RATIONALE: Vaccines made from DNA may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with kidney cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and feasibility of vaccination with human and mouse prostate-specific membrane antigen (PSMA) DNA in patients with renal cell carcinoma.
  • Determine the maximum tolerated dose of this regimen in these patients.
  • Determine antibody responses to human PSMA in patients treated with this regimen.

Secondary

  • Assess antitumor response in patients treated with this regimen.

OUTLINE: This is a randomized, dose-escalation study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive human prostate-specific membrane antigen (PSMA) DNA vaccine intramuscularly (IM) once every 3 weeks for 3 doses (doses 1-3). Patients then receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses (doses 4-6).
  • Arm II: Patients receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses (doses 1-3). Patients then receive human PSMA DNA vaccine IM once every 3 weeks for 3 doses (doses 4-6).

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional booster vaccinations with the second form of PSMA DNA vaccine received (for doses 4-6) every 8 weeks for up to 4 additional doses.

Cohorts of 3-6 patients per arm receive escalating doses of human and mouse PSMA DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 2 years.

Conditions
Kidney Cancer
Being tested
human prostate-specific membrane antigen plasmid DNA vaccine, mouse prostate-specific membrane antigen plasmid DNA vaccine
Keywords
recurrent renal cell cancer, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

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

  • human prostate-specific membrane antigen plasmid DNA vaccineBiological

  • mouse prostate-specific membrane antigen plasmid DNA vaccineBiological

Study groups in NCT00096629
Study groupRoleWhat they receive
human PSMAExperimentalPatients will receive a total of 6 vaccinations via the intramuscular route. Sites of injection should have intact lymphatic drainage. Groups of six patients will be randomized at each dose level, 3 for each arm, to receive either three immunizations with mouse PSMA followed by three immunizations with human PSMA or three immunizations with human PSMA followed by three immunizations with mouse PSMA.
Receives: Biological: human prostate-specific membrane antigen plasmid DNA vaccine; Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine
mouse PSMAExperimentalPatients will receive a total of 6 vaccinations via the intramuscular route. Sites of injection should have intact lymphatic drainage. Groups of six patients will be randomized at each dose level, 3 for each arm, to receive either three immunizations with mouse PSMA followed by three immunizations with human PSMA or three immunizations with human PSMA followed by three immunizations with mouse PSMA.
Receives: Biological: human prostate-specific membrane antigen plasmid DNA vaccine; Biological: mouse prostate-specific membrane antigen plasmid DNA vaccine

What is being measured

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

  1. safety

    Measured: 2 years

  2. feasibility

    Measured: 2 years

Secondary outcomes (2)

  1. antibody responses

    Measured: 2 years

  2. anti-tumor response

    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 posted15 Nov 2004 (estimated)
  2. Study startNov 2003
  3. Primary completionApr 2018
  4. Study completionApr 2018

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096629
Sponsor's protocol ID
03-125
Other IDs
MSKCC-03125
Status last verified
Apr 2018
First submitted
12 Nov 2004
Last updated
25 Apr 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing human prostate-specific membrane antigen plasmid DNA vaccine and mouse prostate-specific membrane antigen plasmid DNA vaccine in people with Kidney Cancer, 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: finished, as of the sponsor's last update on 25 Apr 2018. 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 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 (time frame: 2 years). The study lists 2 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 NCT00096629.

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 25 Apr 2018.

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