A Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/20/2019 |
| Start Date: | April 2019 |
| End Date: | February 2023 |
| Contact: | Denise Gallagher, RN |
| Email: | phase1trials@jhmi.edu |
| Phone: | 410-502-5140 |
A Phase 1b Window of Opportunity Study to Investigate Mechanisms of Actions of Novel Therapeutic Agents in Patients With Resectable Solid Tumor Malignancies
This is a single-institution, single arm, open label, window of opportunity clinical trial
that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects
of the novel study drugs in subjects with resectable solid tumor malignancies.
Each Sub-protocol conducted under the Master Protocol will evaluate different novel
therapeutic agent(s).
Estimated enrollment is 15 subjects per Sub-Protocol.
that will act as a Master Protocol with a primary objective to assess pharmacodynamic effects
of the novel study drugs in subjects with resectable solid tumor malignancies.
Each Sub-protocol conducted under the Master Protocol will evaluate different novel
therapeutic agent(s).
Estimated enrollment is 15 subjects per Sub-Protocol.
Patients will have a short-course (4-weeks) administration of a given compound in the
timeframe between the diagnostic biopsy and the surgical resection. A pre-treatment tumor
biopsy will be obtained, and blood samples will be collected before, during, and at the end
of treatment.
timeframe between the diagnostic biopsy and the surgical resection. A pre-treatment tumor
biopsy will be obtained, and blood samples will be collected before, during, and at the end
of treatment.
Inclusion Criteria:
1. Must have biopsy-proven solid tumor that is eligible for elective surgical resection,
disease does not require immediate therapy, and there is NO approved/ standard therapy
available that is shown to prolong overall survival.
2. ECOG performance status of 0 or 1.
3. Must have a tumor lesion that is amenable to biopsy, and willing to undergo biopsy.
4. Willing to provide tissue and blood samples for research.
Exclusion Criteria:
1. The following solid tumors are NOT eligible: Primary brain tumor, Ocular melanoma,
Head and neck cancer, Breast cancer, Prostate cancer, Testicular cancer, and Stage III
rectal cancer.
2. Any active malignancy within 3 years prior, except: Adequately treated basal cell or
squamous cell skin cancer, or early stage cancers (carcinoma in situ or stage 1)
treated with curative intent.
3. Any uncontrolled intercurrent illness, including but not limited to: Symptomatic
congestive heart failure, Unstable angina pectoris or coronary angioplasty or stenting
within 6 months prior to enrollment, Cardiac arrhythmia, Psychiatric illness or social
situations that would limit compliance with study requirements, or Ongoing or active
infection.
4. Any known sensitivity to or history of allergic reaction to compounds of similar
chemical or biological composition of study drug(s).
5. Unwilling or unable to follow the study schedule.
Other protocol defined inclusion/exclusion criteria may apply.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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