Stage III or Stage IV MelanomaPhase 1/2NCT00675727
Safety Study of CADI-05 in Patients With Advanced Stage Melanoma
A Phase 1/2 study testing CADI-05 in people with Stage III or Stage IV Melanoma, run by Cadila Pharnmaceuticals at 1 site in United States.
Trial summary
This study examines the safety of treating patients with advanced stage melanoma with the vaccine CADI-05. In addition, preliminary data regarding the clinical response and immune response will be collected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III or Stage IV Melanoma
- What is being tested?
- CADI-05
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Ability to understand and the willingness to sign a written informed consent document
- Subject must have a pathologic diagnosis malignant melanoma (stage III or IV).
- Subject must have at least one of the following:
- Melanoma that was previously treated with at least one complete or partial course of therapy for melanoma with either a poor to no response or evidence of disease progression;
- Melanoma that cannot be treated with first-line therapies because of medical comorbidities/risk of toxicity; or
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- Melanoma that has not been treated with first-line therapies because of patient refusal.
- If melanoma is possibly resectable, the melanoma must have recurred despite at least two attempts at resection.
- The subject must have measurable disease, as defined by the presence of at least one measurable lesion, defined as having longest diameter greater than or equal to 20 mm by conventional measurement techniques (e.g., measurement of evaluable cutaneous metastases) or greater than or equal to 20 mm by imaging studies.
- Subject must have an ECOG performance status of 0, 1, or 2.
- Subject must have the ability to understand and provide informed consent that fulfills Institutional Review Board guidelines. Alternatively, if the subject is mentally incompetent for medical decision-making, a parent, legal guardian, or power of attorney has the ability to understand and provide informed consent that fulfills Institutional Review Board guidelines.
- Subject must be able to comply with office visits as required by the protocol.
- The effects of Investigational product on the developing human fetus is at the recommended therapeutic dose are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Who cannot join
- Subjects with medical co-morbidities, which in the judgment of the investigator, place them at an unacceptable level of risk for participation in this study.
- Pregnant women, since the prenatal effects of CADI-05 have not been characterized.
- Subjects with HIV, AIDS, or chronic immunosuppression for organ transplantation.
- Subjects who are unable to comply with office visits as required by this protocol or would suffer great hardship by participating in the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
- Clinically significant active infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
About this study
Official title: Open Label, Single Arm, Phase I/II Study of CADI-05 in Patients With Advanced Stage III or Stage IV Melanoma
This study examines the safety of treating patients with advanced stage melanoma with the vaccine CADI-05. In addition, preliminary data regarding the clinical response and immune response will be collected.
Read the detailed description
Because there are no highly effective treatment options for patients with advanced, unresectable melanoma, participation in clinical trials of novel therapies is frequently the best therapeutic alternative. CADI-05 is a promising agent for two reasons. First, patients with advanced melanoma frequently have disturbing symptoms such as anorexia with associated weight loss, fatigue, and chemotherapy-associated side effects such as nausea and vomiting. CADI-05 not only has a very low side effect profile, but it actually improves such symptoms. Second, melanomas are generally immunogenic, and sometimes patients mount significant of immune responses to cause spontaneous regression of tumors. High-dose interleukin-2, a relatively toxic therapy that stimulates the immune system, causes long-term regression in stage IV melanoma in a small percentage of patients. In addition, when combined with adoptive immunotherapy, response rates as high as 50% have been observed. Therefore, induction of potent antitumor immune responses in melanoma can be a highly effective therapeutic modality. Because CADI-05 has potent immunostimulatory effects and an excellent side effect profile, it is a very attractive option for treatment of stage IV melanoma patients. Preliminary data from ongoing preclinical studies in a murine melanoma model have shown that CADI-05 has significant biological activity in metastatic melanoma (G. Robertson, unpublished data).
Although it is possible that CADI-05 as a single agent will have activity in advanced melanoma, it may also be useful in conjunction with other systemic agents or as an adjuvant in conjunction with immunotherapy regimens. In addition, previous human trials suggest that CADI-05 may be helpful in symptom control and improvement of quality of life in patients with advanced melanoma. In spite of the promising data from a number of preclinical and clinical studies of this agent, no U.S. studies of the effects of CADI-05 in cancer patients have been performed. Therefore, the present research study proposes to evaluate the safety of CADI-05 treatment in advanced melanoma. In addition, preliminary data regarding the clinical response rate and immune response will be collected.
- Conditions
- Stage III or Stage IV Melanoma
- Being tested
- CADI-05
- Keywords
- Melanoma, Mycobacterium w
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADI-05Biological
Two intradermal treatments each week for first 4 weeks followed by one intradermal treatment per week for second 4 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of any clinical adverse reactions at anytime during the study for assessment of safety.
Measured: 6-24 months
Secondary outcomes (1)
Both physical examinations and imaging studies will be used to evaluate clinical response to CADI-05 treatment.
Measured: 6-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2010 (estimated)
Why it stopped: DSMB reviewed data of 1st 10 subjects; determined no safety concerns. Efficacy as a single agent in this patient population was unlikely. Voluntary Termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III or Stage IV MelanomaStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cadila Pharnmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul J Mosca, M.D., Ph.D., Principal investigator, Lehigh Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675727
- Sponsor's protocol ID
- CR-60/4051
- Status last verified
- Jun 2009
- First submitted
- 8 May 2008
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Arm, Phase I/II Study of CADI-05 in Patients With Advanced Stage III or Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT00675727
- Acronym / sponsor ID
- CR-60/4051
- Conditions
- Stage III or Stage IV Melanoma
- Keywords
- Melanoma, Mycobacterium w
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB reviewed data of 1st 10 subjects; determined no safety concerns. Efficacy as a single agent in this patient population was unlikely. Voluntary Termination
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2010 (estimated)
- First posted
- 12 May 2008 (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.
This study examines the safety of treating patients with advanced stage melanoma with the vaccine CADI-05. In addition, preliminary data regarding the clinical response and immune response will be collected.
Detailed description
Because there are no highly effective treatment options for patients with advanced, unresectable melanoma, participation in clinical trials of novel therapies is frequently the best therapeutic alternative. CADI-05 is a promising agent for two reasons. First, patients with advanced melanoma frequently have disturbing symptoms such as anorexia with associated weight loss, fatigue, and chemotherapy-associated side effects such as nausea and vomiting. CADI-05 not only has a very low side effect profile, but it actually improves such symptoms. Second, melanomas are generally immunogenic, and sometimes patients mount significant of immune responses to cause spontaneous regression of tumors. High-dose interleukin-2, a relatively toxic therapy that stimulates the immune system, causes long-term regression in stage IV melanoma in a small percentage of patients. In addition, when combined with adoptive immunotherapy, response rates as high as 50% have been observed. Therefore, induction of potent antitumor immune responses in melanoma can be a highly effective therapeutic modality. Because CADI-05 has potent immunostimulatory effects and an excellent side effect profile, it is a very attractive option for treatment of stage IV melanoma patients. Preliminary data from ongoing preclinical studies in a murine melanoma model have shown that CADI-05 has significant biological activity in metastatic melanoma (G. Robertson, unpublished data).
Although it is possible that CADI-05 as a single agent will have activity in advanced melanoma, it may also be useful in conjunction with other systemic agents or as an adjuvant in conjunction with immunotherapy regimens. In addition, previous human trials suggest that CADI-05 may be helpful in symptom control and improvement of quality of life in patients with advanced melanoma. In spite of the promising data from a number of preclinical and clinical studies of this agent, no U.S. studies of the effects of CADI-05 in cancer patients have been performed. Therefore, the present research study proposes to evaluate the safety of CADI-05 treatment in advanced melanoma. In addition, preliminary data regarding the clinical response rate and immune response will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least 18 years of age
- Ability to understand and the willingness to sign a written informed consent document
- Subject must have a pathologic diagnosis malignant melanoma (stage III or IV).
- Subject must have at least one of the following:
- If melanoma is possibly resectable, the melanoma must have recurred despite at least two attempts at resection.
Key exclusion criteria (6 listed)
- Subjects with medical co-morbidities, which in the judgment of the investigator, place them at an unacceptable level of risk for participation in this study.
- Pregnant women, since the prenatal effects of CADI-05 have not been characterized.
- Subjects with HIV, AIDS, or chronic immunosuppression for organ transplantation.
- Subjects who are unable to comply with office visits as required by this protocol or would suffer great hardship by participating in the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
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 |
|---|---|---|
| CADI-05Two intradermal treatments each week for first 4 weeks followed by one intradermal treatment per week for second 4 weeks. | Biological | – |
Primary outcome
Recording of any clinical adverse reactions at anytime during the study for assessment of safety.
Time frame: 6-24 months
1 secondary outcome
Both physical examinations and imaging studies will be used to evaluate clinical response to CADI-05 treatment.
Time frame: 6-24 months
Results and safety
The study was stopped early (reason given: DSMB reviewed data of 1st 10 subjects; determined no safety concerns. Efficacy as a single agent in this patient population was unlikely. Voluntary Termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
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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.
Paul J Mosca, M.D., Ph.D. principal investigator
Lehigh Valley Hospital
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 CADI-05 in people with Stage III or Stage IV Melanoma, run by Cadila Pharnmaceuticals 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 13 inclusion and 6 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 11 Jun 2009. 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 (reason given: DSMB reviewed data of 1st 10 subjects; determined no safety concerns. Efficacy as a single agent in this patient population was unlikely. Voluntary Termination). 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?
Recording of any clinical adverse reactions at anytime during the study for assessment of safety. (time frame: 6-24 months). 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 11 Jun 2009.