| Eligibility |
Inclusion Criteria:
- Patients must have histologically confirmed rare solid tumors that have progressed on
standard therapy or for whom there is no longer standard of care therapy. Other rare
tumor types may be acceptable at the discretion of the principal investigator (PI)
- Patients must not be eligible for a higher priority study, such as a disease
specific study of phase 2 or higher or a randomized study. Specifically, patients
with pheochromocytoma and paraganglioma at the clinical center will be eligible
for this study if they are not eligible for the NCT04394858 due to prior PARP
inhibitor, dacarbazine (DTIC) or temozolomide therapy
- Patients must have measurable disease as defined by Response Evaluation Criteria in
Solid Tumors (RECIST) version (v)1.1, with at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded for non-nodal
lesions and short axis for nodal lesions)
- Patients consenting to biopsies must have a tumor site amenable to biopsy. If
avoidable, the lesion for biopsy should not be selected as a target lesion for RECIST
measurements
- Prior to entering the study, patients must have:
- >= 3 weeks since completion of radiation therapy or major surgery
- >= 5 half-lives or 3 weeks (whichever is shorter) since completion of biologic
therapy or chemotherapy
- Should be at least 6 weeks out from nitrosoureas and mitomycin C
- >= 2 weeks since any prior administration of a study drug in a Phase 0 or
equivalent study
- >= 1 week from palliative radiation therapy (patients on study may be eligible
for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at
the PI's discretion)
- Recovered to eligibility levels from prior toxicity or adverse events. Treatment
with bisphosphonates is permitted
- Adults age >= 18 years; children/adolescents age >= 12 years to 17 years with body
surface area (BSA) >= 1.5 m^2
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 8 g/dL
- Total bilirubin =< 1.5 X institutional upper limit of normal (=< 3 x upper limit of
normal in the presence of documented Gilbert's syndrome or liver metastases at
baseline)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 3 X upper limit of normal (ULN)
- Creatinine clearance >= 60 mL/min/1.73 m^2 OR creatinine for adult patients: =< 1.5 X
institutional ULN, for pediatric patients (< 18 years of age):
- 2 to < 6 years (0.8 mg/dL male, 0.8 mg/dL female)
- 6 to < 10 years (1 mg/dL male, 1 mg/dL female)
- 10 to < 13 years (1.2 mg/dL male, 1.2 mg/dL female)
- 13 to < 16 years (1.5 mg/dL male, 1.4 mg/dL female)
- 16 to < 18 years (1.7 mg/dL male, 1.4 mg/dL female)
- Talazoparib and temozolomide can cause fetal harm based on animal reproductive and
genetic toxicity studies. For this reason, women of child-bearing 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 and for
at least 7 months after dosing with study drugs ceases. Should a woman become pregnant
or suspect she is pregnant while she or her partner is participating in this study,
she should inform her treating physician immediately. Men treated or enrolled on this
protocol must also agree to use adequate contraception prior to the study, for the
duration of study participation, and 7 months after completion of study drug
administration. Women of child-bearing potential must have a negative pregnancy test
(urine or serum) in the 8 days prior to beginning treatment, and again on cycle 1 day
1 of treatment
- Biopsies are optional on this study. In lieu of baseline biopsies, patients are
encouraged to submit at registration archival tumor biopsy tissue from a previous
research study or medical care providing it meets the minimum collection and
preservations requirements. Criteria for the submission of archival tissue are:
- Tissue must have been collected within 3 months prior to registration
- Patient must not have received any intervening therapy for their cancer since the
collection of the tumor sample
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial. For
these patients, an HIV viral load test must be completed within 28 days prior to
enrollment
- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Sensory/motor neuropathy >= grade 2
- Patients who are receiving any other investigational agents
- Patients with active brain metastases or carcinomatous meningitis are excluded from
this clinical trial. Patients with treated brain metastases, whose brain metastatic
disease has remained stable for >= 1 month without requiring steroid and anti-seizure
medication are eligible to participate
- History of allergic reactions attributed to compounds of similar chemical composition
to study drugs
- Known clinically significant liver disease, including active viral, alcoholic, or
other hepatitis; cirrhosis; fatty liver; and inherited liver disease
- Patients with past or resolved hepatitis B infection (defined as having a
negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc
[antibody to hepatitis B core antigen] antibody test) are eligible. For these
patients, HBsAg and anti-HBc tests must be done within 28 days prior to
enrollment
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if
polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). For
these patients, an HCV RNA test must be done within 28 days prior to enrollment
- Uncontrolled intercurrent illness including, but not limited to, serious untreated
infection, symptomatic respiratory failure/congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements
- Pregnant women are excluded from this study because temozolomide and talazoparib have
demonstrated fetal harm in animal reproductive studies. Because there is an unknown
but potential risk for adverse events in nursing infants secondary to treatment of the
mother with the study drugs, breastfeeding should be discontinued prior to the first
dose of study drug and women should refrain from nursing throughout the treatment
period and for 1 months following the last dose of study drug
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