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Open Label, Single Arm, Phase I/II Study of CADI-05 in Patients With Advanced Stage III or Stage IV Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling
Stage III or Stage IV Melanoma

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Trial Information

Open Label, Single Arm, Phase I/II Study of CADI-05 in Patients With Advanced Stage III or Stage IV Melanoma

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Robertson, unpublished data).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.

Inclusion Criteria:

- 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:

1. 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;

2. Melanoma that cannot be treated with first-line therapies because of medical
comorbidities/risk of toxicity; or

3. Melanoma that has not been treated with first-line therapies because of patient

- 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.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recording of any clinical adverse reactions at anytime during the study for assessment of safety.

Outcome Time Frame:

6-24 months

Safety Issue:


Principal Investigator

Paul J Mosca, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lehigh Valley Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

Related Keywords:

  • Stage III or Stage IV Melanoma
  • Melanoma
  • Mycobacterium w
  • Melanoma



Lehigh Valley Hospital Allentown, Pennsylvania  18103