Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00030693
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
A Phase 1 study testing recombinant fowlpox-B7.1 vaccine, recombinant fowlpox-TRICOM vaccine and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- recombinant fowlpox-B7.1 vaccine, recombinant fowlpox-TRICOM vaccine and laboratory biomarker analysis
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Apr 2010
- 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
Who may be able to join
- Histologically confirmed metastatic unresectable solid tumors
- Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
- No standard therapy available
- At least 1 unidimensionally measurable lesion
- At least 20 mm for visceral lesions
- At least 10 mm for cutaneous, subcutaneous, and nodal lesions
Show all 42Show fewer
- No untreated or edematous metastatic brain lesions
- At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
- No ascites or pleural effusions
- No leptomeningeal disease
- Performance status - ECOG 0-1
- More than 3 months
- Absolute granulocyte count at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding diathesis
- Bilirubin no greater than 1.5 mg/dL*
- SGOT/SGPT no greater than 2 times upper limit of normal (ULN)*
- Alkaline phosphatase no greater than 2 times ULN*
- No elevated PT or PTT
- No cirrhosis
- No active hepatitis
- No hepatic insufficiency
- Creatinine no greater than 2.0 mg/dL
- No renal insufficiency
- No chronic obstructive pulmonary disorder
- No active autoimmune disorders
- No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis)
- No significant allergy or hypersensitivity to eggs
- No active seizure disorder
- No active or chronic infections
- No other significant medical disease that would preclude study participation
- No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- More than 8 weeks since prior immunotherapy and recovered
- More than 4 weeks since prior chemotherapy and recovered
- At least 4 weeks since prior systemic corticosteroids
- No concurrent corticosteroids
- More than 2 weeks since prior radiotherapy and recovered
- No evidence of bone marrow toxicity from prior radiotherapy
- More than 4 weeks since prior surgery and recovered
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors
Read the detailed description
PRIMARY OBJECTIVES:
- To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible cutaneous, subcutaneous, or lymph node metastatic tumors.
II. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors.
III. To determine the optimal dose of rF-B7.1 and rF-TRICOM vaccine delivered by intra-tumoral injection.
IV. To compare the clinical responses and safety profile of patients with cutaneous tumors and visceral tumors who receive rF-B7.1 vaccine to similar patients receiving rF-TRICOM vaccine.
SECONDARY OBJECTIVES:
- To establish evidence of host anti-tumor immune reactivity following intra-lesional vaccine administration and compare any differences between rF-B7.1 and rF-TRICOM in patients with cutaneous tumors and visceral tumors.
II. To evaluate the quality of life during vaccine administration.
OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral metastases). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rF-B7.1 vaccine intratumorally on day 1.
ARM II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses.
Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment.
Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy.
Patients are followed every 3 months.
- Being tested
- recombinant fowlpox-B7.1 vaccine, recombinant fowlpox-TRICOM vaccine, laboratory biomarker analysis, quality-of-life assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant fowlpox-B7.1 vaccineBiological
Also called rF-B7.1, rF-B7.1 vaccine
Given intratumorally
recombinant fowlpox-TRICOM vaccineBiological
Also called rF-TRICOM (B7.1.iCAM1-LFA3-Fowlpox)
Given intratumorally
laboratory biomarker analysisOther
Correlative studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (recombinant fowlpox-B7.1 vaccine) | Experimental | Patients receive rF-B7.1 vaccine intratumorally on day 1. Receives: Biological: recombinant fowlpox-B7.1 vaccine; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment |
| Arm II (recombinant fowlpox-TRICOM vaccine) | Experimental | Patients receive fowlpox-TRICOM vaccine intratumorally on day 1. Receives: Biological: recombinant fowlpox-TRICOM vaccine; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of the DLTEs
Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.
Measured: 12 weeks
Secondary outcomes (3)
Proportion of patients with any response (CR, PR, or SD)
First, the proportion with any response (CR, PR or SD) will be compared to those with no response (PD). Secondly, the proportion of any response (CR, PR or SD) compared to no response (PD) will be compared between the two treatment arms.
Measured: 12 weeks
Immune response
Number of T-cells after treatment compared to those measured at baseline, and difference calculated as after-treatment minus baseline. First comparison includes all subjects who completed treatment. Mean change in T-Cells (final-baseline) tested against 0 with 2-tailed, 1-sample t-test, with alpha=.05. Second analysis compares mean change in T-Cells between arms. Performed as a 2-tailed, 2 independent samples t-test, with alpha=.05. Third comparison is a sub-set analysis of patients with melanoma.
Measured: 12 weeks
Change in quality of life, assessed using the FACT-G survey of emotional and functional well being
A mean observed change in the FACT-G score will be tested against 0 (no change) for the group as a whole. Secondly, the change in score will be compared between the two treatment arms. The overall mean change will also be compared to historical controls either from the literature for cancer patients or to the values for non-subject cancer patients receiving other therapies. Comparisons will be by t-test if the sample distribution meets parametric assumptions. If not non-parametric procedures will be used.
Measured: Baseline to 12 weeks
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 startDec 2001
- Primary completionApr 2010
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Howard Kaufman, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030693
- Sponsor's protocol ID
- NCI-2012-02455
- Other IDs
- CPMC-IRB-14535, CDR0000069189
- Status last verified
- Jan 2013
- First submitted
- 14 Feb 2002
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Lesional rF-B7.1 Versus rF-Tricom Vaccine In The Treatment Of Metastatic Cancer
- ClinicalTrials.gov ID
- NCT00030693
- Acronym / sponsor ID
- NCI-2012-02455
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2001
- Primary completion
- Apr 2010 (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.
Randomized phase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastatic solid tumors
Detailed description
PRIMARY OBJECTIVES:
- To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible cutaneous, subcutaneous, or lymph node metastatic tumors.
II. To determine and compare the feasibility and clinical toxicity of administering rF-B7.1 and rF-TRICOM vaccines to patients with accessible visceral metastatic tumors.
III. To determine the optimal dose of rF-B7.1 and rF-TRICOM vaccine delivered by intra-tumoral injection.
IV. To compare the clinical responses and safety profile of patients with cutaneous tumors and visceral tumors who receive rF-B7.1 vaccine to similar patients receiving rF-TRICOM vaccine.
SECONDARY OBJECTIVES:
- To establish evidence of host anti-tumor immune reactivity following intra-lesional vaccine administration and compare any differences between rF-B7.1 and rF-TRICOM in patients with cutaneous tumors and visceral tumors.
II. To evaluate the quality of life during vaccine administration.
OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral metastases). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive rF-B7.1 vaccine intratumorally on day 1.
ARM II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1.
Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses.
Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment.
Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy.
Patients are followed every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (recombinant fowlpox-B7.1 vaccine) | Experimental | Biological: recombinant fowlpox-B7.1 vaccine, Other: laboratory biomarker analysis, Procedure: quality-of-life assessmentPatients receive rF-B7.1 vaccine intratumorally on day 1. |
| Arm II (recombinant fowlpox-TRICOM vaccine) | Experimental | Biological: recombinant fowlpox-TRICOM vaccine, Other: laboratory biomarker analysis, Procedure: quality-of-life assessmentPatients receive fowlpox-TRICOM vaccine intratumorally on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (42 listed)
- Histologically confirmed metastatic unresectable solid tumors
- At least 1 unidimensionally measurable lesion
- No untreated or edematous metastatic brain lesions
- No ascites or pleural effusions
- No leptomeningeal disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| recombinant fowlpox-B7.1 vaccineAlso: rF-B7.1, rF-B7.1 vaccineGiven intratumorally | Biological | Arm I (recombinant fowlpox-B7.1 vaccine) |
| recombinant fowlpox-TRICOM vaccineAlso: rF-TRICOM (B7.1.iCAM1-LFA3-Fowlpox)Given intratumorally | Biological | Arm II (recombinant fowlpox-TRICOM vaccine) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (recombinant fowlpox-B7.1 vaccine), Arm II (recombinant fowlpox-TRICOM vaccine) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (recombinant fowlpox-B7.1 vaccine), Arm II (recombinant fowlpox-TRICOM vaccine) |
Primary outcome
Percentages of the DLTEs
Time frame: 12 weeks
Will be summarized and compared between arms, doses, and disease groups using Fisher's exact test.
3 secondary outcomes
Proportion of patients with any response (CR, PR, or SD)
Time frame: 12 weeks
Immune response
Time frame: 12 weeks
Change in quality of life, assessed using the FACT-G survey of emotional and functional well being
Time frame: Baseline to 12 weeks
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 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.
Howard Kaufman principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant fowlpox-B7.1 vaccine, recombinant fowlpox-TRICOM vaccine and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) 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 42 inclusion and 0 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: stopped early, as of the sponsor's last update on 24 Jan 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 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 was stopped early (reason given: Administratively complete.). 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.
What does the primary outcome measure?
Percentages of the DLTEs (time frame: 12 weeks). 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 24 Jan 2013.