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Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma

Phase 2
12 Years
70 Years
Open (Enrolling)

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Trial Information

Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive ABI-007 by vein
over about 30 minutes on Days 1, 8, and 15 of each 28-day cycle. During the first 3 months
that you receive ABI-007, you will also receive ipilimumab. You will receive ipilimumab by
vein over about 90 minutes. You will receive it 4 times, each time about 3 weeks apart.

You will be given standard drugs to help decrease the risk of side effects. You may ask the
study staff for information about how the drugs are given and their risks.

Study Tests:

Every week, blood (about 1 teaspoon) will be drawn for routine tests.

Before each cycle of ABI-007:

- Your performance status will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- Blood (about 1 teaspoon) will be drawn for routine tests.

- Blood (about 1 teaspoon) will be drawn for tests of the immune system (first 3 cycles

- You will be asked about any other drugs you may be taking and about any side effects
you may be having.

- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine
pregnancy test.

Every 8 weeks (+/- 7 days), you will have a chest x-ray and CT scans or MRI scans performed
to check the status of the disease.

Length of Study:

You may receive ipilimumab for up to 3 months. You may continue taking ABI-007 for as long
as the doctor thinks it is in your best interest. You will no longer be able to take the
study drugs if the disease gets worse or intolerable side effects occur.

If you stop receiving the study drugs for any reason, you will have an End-of-Treatment

End-of-Treatment Visit:

Within 14 days after you stop study treatment, you will come into the clinic for the
End-of-Treatment Visit. At this visit, the following tests will be performed:

- You will have a physical exam, including measurement of your vital signs and weight.

- You will be asked about any other drugs you may be taking and any side effects you may
be having.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- If the study doctor thinks it is in your best interest, you will have a CT scan or MRI
scan to check for side effects.

Every 2 months for 6 months, then every 3 months for up to 2 years, you will also be
contacted by telephone or during a routine clinic visit to see how you are doing. If you
are called, each call should last about 5 minutes.

This is an investigational study. Ipilimumab is FDA approved and commercially available
for the treatment of metastatic melanoma. ABI-007 is FDA approved and commercially
available for the treatment of metastatic breast cancer. It is investigational to use
ABI-007, either alone or in combination with ipilimumab, for the treatment of metastatic

Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with histologically documented diagnosis of advanced stage IV or
unresectable stage III mucosal or cutaneous melanoma are eligible.

2. They must have recurrent melanoma with measurable or evaluable sites of disease, 1.0
cm or larger, in order to assess the response to treatment by the immune-related
response criteria (irRC).

3. Patients should not have been previously treated with cytotoxic drugs and
immunotherapeutic agents for unresectable Stage III or Stage IV disease. Prior
Ipilimumab in metastatic setting is not allowed. Prior therapy may include one line
of targeted therapy for metastatic disease ie BRAF or MEK inhibitor. Prior adjuvant
interferon is permitted. Prior cytotoxic therapy in adjuvant or metastatic setting is
not allowed. Prior Ipilimumab in adjuvant setting is not allowed. Prior adjuvant
therapy with targeted therapy including but not limited to B-RAF, MEK inhibitors etc.
is allowed. Prior palliative radiation therapy for metastatic melanoma is permitted
provided the patient has unirradiated metastatic sites for response evaluation and
has fully recovered from its toxicity.

4. Patients between 12 years of age and 70 years of age with an ECOG performance status
of 0 or 1 will be eligible

5. They should have normal blood counts with a white blood cell count of more than or
equal to 3000/mm^3 an absolute neutrophil count of more than or equal to 1500/mm^3
and a platelet count of more than 100,000/mm^3, Hemoglobin > 9.0 g/dL and have no
impairment of renal function (serum creatinine less than 1.1 mg/dl for females and
less than 1.4 mg/dl for males), hepatic function (serum bilirubin level of less than
1.5 mg/dl, AST and ALT case AST and ALT of significant cardiac or pulmonary dysfunction.

6. They should have no significant intercurrent illness such as an active infection
associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled
psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active GI
bleeding. Females of child-bearing potential (non-childbearing is defined as greater
than one year post-menopausal or surgically sterilized) must use acceptable
contraceptive methods( abstinence, intrauterine device, oral contraceptive or double
barrier devices) and must have a negative serum or urine pregnancy test within 72
hours prior to beginning treatment on this trial. Sexually active men must also use
acceptable contraceptive methods for the duration of time on study and signed
informed consent .

Exclusion Criteria:

1. Patients with metastatic uveal melanoma

2. Patients with bone metastases only.

3. Patients with symptomatic brain or spinal cord metastases or requiring steroid
therapy and patients with leptomeningeal disease. Patients with treated and stable
CNS metastasis for 3 months or more, off steroids are eligible for the study. No
major surgery or radiation therapy within 21 days before starting treatment.

4. Patients with significant cardiac illness such as symptomatic coronary artery disease
or previous history of myocardial infarction, impaired left ventricle function
(Ejection Fraction less than 50%) on account of any organic disease such as
hypertension or valvular heart disease or serious cardiac arrhythmia requiring
therapy. Patients with significant history of cardiac disease will be evaluated by
the investigator or his designee.

5. Patients with significant impairment of pulmonary function on account of chronic
bronchitis, emphysema or chronic obstructive pulmonary disease (COPD) which has
resulted in impairment of vital capacity of FEV1 to less than 75% of predicted normal

6. Patients with symptomatic effusions on account of pleural, pericardial or peritoneal
metastases of melanoma.

7. Patients who are unable to return for follow-up visits as required by this study.
Patients with a history of second malignant tumor, other than the common skin cancers
- basal and squamous carcinomas, within the past 3 years and uncertainty about the
histological nature of the metastatic lesions. Cases with other types of malignancies
should be reviewed and decided by the PI of the study.

8. Patients with ≥ grade 2 sensory neuropathy at baseline.

9. Patients who have had major surgery or radiation therapy within 21 days of starting

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Primary efficacy endpoint is rate of progression-free survival (PFS) at 6 months. At end of the study, if there are more than 14 patients who are alive and progression free at 6 months among the 64 patients, the ABI-007 plus Ipilimumab combination will be considered successful and will be considered for further study. Simon's minimax two-stage design used to perform interim efficacy monitoring.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Agop Y. Bedikian, MD,BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma
  • Metastatic Melanoma
  • Advanced stage IV melanoma
  • Unresectable stage III mucosal melanoma
  • Cutaneous melanoma
  • Progression-free survival
  • (PFS)
  • ABI-007
  • Nab-paclitaxel
  • Paclitaxel
  • Abraxane
  • Ipilimumab
  • Yervoy
  • BMS-734016
  • MDX010
  • Melanoma



University of Texas MD Anderson Cancer Center Houston, Texas  77030